Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT01436656
Status:
COMPLETED
Last Update Posted:
2024-10-28
First Post:
2011-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601108', 'term': 'encorafenib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.', 'description': 'Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Escalation: 50 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Dose Escalation: 100 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 3, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Dose Escalation:150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Dose Escalation: 75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Dose Escalation: 200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Dose Escalation: 100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Dose Escalation: 300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'Dose Escalation: 150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Dose Escalation: 450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Dose Escalation: 550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'Dose Escalation: 700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'Dose Expansion: Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG012', 'title': 'Dose Expansion: Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 4}, {'id': 'EG013', 'title': 'Dose Expansion: Mel Pre-treated 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG014', 'title': 'Dose Expansion: Mel Pre-treated 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'deathsNumAffected': 11, 'seriousNumAffected': 9}, {'id': 'EG015', 'title': 'Dose Expansion: Mel Stepwise 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG016', 'title': 'Dose Expansion: Metastatic Colorectal Cancer 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 5, 'seriousNumAffected': 3}, {'id': 'EG017', 'title': 'Dose Expansion: Metastatic Colorectal Cancer 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 8, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ichthyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Keratosis follicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 9}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 9}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Xerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 8}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 13}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 9}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 10}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acanthosis nigricans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 8}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 8}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hair texture abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotrichosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intertrigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Keratosis pilaris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 9}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 11}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Palmoplantar keratoderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash follicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vitiligo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemangioma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Seborrhoeic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'VIIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oral hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Brain herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysplastic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Facial paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Obstruction gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Squamous cell carcinoma of head and neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'VIIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose-Limiting Toxicity (DLT) During Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '100 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: \\>=grade (G)3 neutropenia or thrombocytopenia for \\>7 days; G4 thrombocytopenia; febrile neutropenia; \\>=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (\\>=G3 for \\> 7 consecutive days or G4); \\>=G3 ALT or AST and \\>=G2 blood bilirubin; \\>=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for \\>7 consecutive days; \\>= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; \\>=G3 pancreatitis, rash/photosensitivity (G3 for \\> 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Determining Set (DDS) consisted of all participants from the safety set who either met the following minimum exposure (received at least 75% of the planned doses of encorafenib in Cycle 1; observed for at least 1 cycle and considered to have sufficient safety data to conclude that a DLT did not occur in cycle 1) and had completed scheduled safety evaluations or experienced a DLT.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With DLT During Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: \\>=grade (G)3 neutropenia or thrombocytopenia for \\>7 days; G4 thrombocytopenia; febrile neutropenia; \\>=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (\\>=G3 for \\> 7 consecutive days or G4); \\>=G3 ALT or AST and \\>=G2 blood bilirubin; \\>=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for \\>7 consecutive days; \\>= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; \\>=G3 pancreatitis, rash/photosensitivity (G3 for \\> 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DDS consisted of all participants from the safety set who either met the following minimum exposure criterion (received at least 75% of the planned doses of encorafenib in Cycle 1; observed for at least 1 cycle and considered to have sufficient safety data to conclude that a DLT did not occur in cycle 1) and had completed scheduled safety evaluations or experienced a DLT.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '100 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity'}, {'id': 'OG002', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure)', 'description': 'An AE was defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions. An SAE was defined as one of the following: fatal or life-threatening; resulted in significant disability/incapacity; congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization unless for routine treatment, elective or pre-planned treatment for a pre-existing condition, treatment on an emergency outpatient basis, social reasons and respite care in the absence of any deterioration in the participants general condition, any SAEs that were expected due to the condition being treated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received at least one dose of encorafenib and had at least one valid post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With AEs and SAEs During Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until 30 days after last dose of study treatment (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'An AE was defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions. An SAE was defined as one of the following: fatal or life-threatening; resulted in significant disability/incapacity; congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization unless for routine treatment, elective or pre-planned treatment for a pre-existing condition, treatment on an emergency outpatient basis, social reasons and respite care in the absence of any deterioration in the participants general condition, any SAEs that were expected due to the condition being treated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received at least one dose of encorafenib and had at least one valid post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS): Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '100 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity'}, {'id': 'OG002', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '88.2'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '40.0', 'groupId': 'OG005', 'lowerLimit': '5.3', 'upperLimit': '85.3'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '52.2'}, {'value': '75.0', 'groupId': 'OG007', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '33.3', 'groupId': 'OG008', 'lowerLimit': '4.3', 'upperLimit': '77.7'}, {'value': '20.0', 'groupId': 'OG009', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '0.0', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 556.1 weeks of treatment exposure)', 'description': 'PFS was defined as time from date of first study treatment intake to date of first documented disease progression (PD) or death due to any cause. If a participant did not have an event, data censoring was done at the date of last adequate tumor assessment. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of greater than or equal to (\\>=) 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who received at least one dose of encorafenib.'}, {'type': 'SECONDARY', 'title': 'PFS: Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'comment': 'Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': 'NA'}, {'value': '19.3', 'comment': 'Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': 'NA'}, {'value': '0.6', 'comment': 'Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': 'NA'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '3.7'}, {'value': '20.1', 'comment': 'Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': '10.9', 'upperLimit': 'NA'}, {'value': '4.5', 'groupId': 'OG005', 'lowerLimit': '2.3', 'upperLimit': '7.2'}, {'value': '4.0', 'groupId': 'OG006', 'lowerLimit': '1.8', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'PFS was defined as time from date of first study treatment intake to date of first documented PD or death due to any cause. If a participant did not have an event, data censoring was done at the date of last adequate tumor assessment. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of \\>= 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least one dose of encorafenib.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR): Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '100 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity'}, {'id': 'OG002', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first observation of response until first time of PD or death due to any cause (Maximum of 556.1 weeks of treatment exposure)', 'description': 'DOR was defined as the time from first observation of response CR or partial response \\[PR\\]) to the first time of progression or death. CR was defined as complete disappearance of all target and non-target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\\<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \\>= 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least one dose of encorafenib. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis."}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR): Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '100 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity'}, {'id': 'OG002', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'title': 'Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '952', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Participant 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '897', 'groupId': 'OG002'}]}]}, {'title': 'Participant 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Participant 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Participant 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG004'}]}]}, {'title': 'Participant 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG004'}]}]}, {'title': 'Participant 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG008'}]}]}, {'title': 'Participant 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '627', 'groupId': 'OG008'}]}]}, {'title': 'Participant 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG009'}]}]}, {'title': 'Participant 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Participant 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '280', 'groupId': 'OG005'}]}]}, {'title': 'Participant 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Participant 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG007'}]}]}, {'title': 'Participant 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG007'}]}]}, {'title': 'Participant 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '727', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of start of treatment until CR or PR or censoring date (maximum of 556.1 weeks of treatment exposure)', 'description': 'TTR was defined as the time from date of treatment until first documented response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \\<10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. Individual participant data have been reported for this outcome measure.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least one dose of encorafenib.'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis."}, {'type': 'SECONDARY', 'title': 'DOR: Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first observation of response until first time of PD or death due to any cause (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'DOR was defined as the time from first observation of response (CR or PR\\] to the first time of progression or death. CR was defined as complete disappearance of all target and non-target lesions and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to (\\<10 mm. PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \\>= 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least one dose of encorafenib.'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis."}, {'type': 'SECONDARY', 'title': 'TTR: Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'title': 'Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}]}]}, {'title': 'Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Participant 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Participant 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Participant 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Participant 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Participant 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'Participant 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '391', 'groupId': 'OG003'}]}]}, {'title': 'Participant 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'Participant 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'Participant 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Participant 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG004'}]}]}, {'title': 'Participant 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of start of treatment until CR or PR or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'TTR was defined as the time from date of treatment until first documented response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \\<10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. Individual participant data have been reported for this outcome measure.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least one dose of encorafenib. 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis."}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS): Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': 'NA'}, {'value': '12.5', 'comment': 'Upper limit of 95% CI could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': 'NA'}, {'value': '9.5', 'groupId': 'OG003', 'lowerLimit': '3.7', 'upperLimit': '13.2'}, {'value': 'NA', 'comment': 'Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': '30.7', 'upperLimit': 'NA'}, {'value': '7.2', 'groupId': 'OG005', 'lowerLimit': '5.6', 'upperLimit': '10.5'}, {'value': '8.0', 'comment': 'Upper limit of 95% CI could not be calculated due to insufficient number of participants with events', 'groupId': 'OG006', 'lowerLimit': '4.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment until date of death or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'Overall survival was defined as the time from the date of first study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least one dose of encorafenib.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration of LGX818: Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD (Capsules)', 'description': 'Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '50 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': '100 mg Encorafenib QD (Capsules)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '100 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '100 mg of Encorafenib BID (Microemulsion)', 'description': 'Participants received 200 mg of LGX818 orally once daily for each 28-day treatment cycle until disease progression, withdrawal of consent, unacceptable toxicity, or termination of treatment, followed by a 30-day safety assessment for toxicity.'}, {'id': 'OG008', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG011', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG012', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '970', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed', 'groupId': 'OG000'}, {'value': '846', 'spread': '82.92', 'groupId': 'OG001'}, {'value': '1630', 'spread': '42.36', 'groupId': 'OG002'}, {'value': '1020', 'spread': '49.06', 'groupId': 'OG003'}, {'value': '1570', 'spread': '28.82', 'groupId': 'OG004'}, {'value': '733', 'spread': '46.32', 'groupId': 'OG005'}, {'value': '1850', 'spread': '28.06', 'groupId': 'OG006'}, {'value': '1200', 'spread': '28.06', 'groupId': 'OG007'}, {'value': '3310', 'spread': '42.54', 'groupId': 'OG008'}, {'value': '2510', 'spread': '58.15', 'groupId': 'OG009'}, {'value': '5970', 'spread': '56.35', 'groupId': 'OG010'}, {'value': '5360', 'spread': '36.87', 'groupId': 'OG011'}, {'value': '8980', 'spread': '13.5', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '465', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed', 'groupId': 'OG000'}, {'value': '334', 'spread': '57.7', 'groupId': 'OG001'}, {'value': '959', 'spread': '25.19', 'groupId': 'OG002'}, {'value': '949', 'spread': '27.4', 'groupId': 'OG003'}, {'value': '1300', 'spread': '29.08', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG005'}, {'value': '1300', 'spread': '1220', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG007'}, {'value': '2920', 'spread': '34.41', 'groupId': 'OG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG009'}, {'value': '3950', 'spread': '49.12', 'groupId': 'OG010'}, {'value': '4170', 'spread': '48.94', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic Analysis Set (PAS) consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Time Point of Maximum Concentration (Tmax) of LGX818: Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD (Capsules)', 'description': 'Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '50 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': '100 mg Encorafenib QD (Capsules)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '100 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG011', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG012', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.167', 'upperLimit': '0.500'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG004', 'lowerLimit': '0.517', 'upperLimit': '3.95'}, {'value': '2.02', 'groupId': 'OG005', 'lowerLimit': '2', 'upperLimit': '4.08'}, {'value': '2', 'groupId': 'OG006', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG007', 'lowerLimit': '2', 'upperLimit': '2.08'}, {'value': '2', 'groupId': 'OG008', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '1.25', 'groupId': 'OG009', 'lowerLimit': '0.5', 'upperLimit': '2.25'}, {'value': '2', 'groupId': 'OG010', 'lowerLimit': '2', 'upperLimit': '2.33'}, {'value': '2', 'groupId': 'OG011', 'lowerLimit': '2', 'upperLimit': '2.07'}, {'value': '2.04', 'groupId': 'OG012', 'lowerLimit': '2', 'upperLimit': '2.08'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2'}, {'value': '2.99', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '0.533'}, {'value': '2', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '2.03'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG006', 'lowerLimit': '2', 'upperLimit': '2.17'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG008', 'lowerLimit': '2', 'upperLimit': '2.02'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG010', 'lowerLimit': '0.5', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG011', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG012', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of LGX818: Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD (Capsules)', 'description': 'Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '50 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': '100 mg Encorafenib QD (Capsules)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '100 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG011', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG012', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '5470', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '2340', 'spread': '70.37', 'groupId': 'OG001'}, {'value': '7660', 'spread': '83.44', 'groupId': 'OG002'}, {'value': '5050', 'spread': '39.57', 'groupId': 'OG003'}, {'value': '9520', 'spread': '20.11', 'groupId': 'OG004'}, {'value': '2220', 'spread': '53.66', 'groupId': 'OG005'}, {'value': '9910', 'spread': '26.24', 'groupId': 'OG006'}, {'value': '4410', 'spread': '69.51', 'groupId': 'OG007'}, {'value': '20000', 'spread': '33.36', 'groupId': 'OG008'}, {'value': '8940', 'spread': '50', 'groupId': 'OG009'}, {'value': '33100', 'spread': '70.34', 'groupId': 'OG010'}, {'value': '31900', 'spread': '45.51', 'groupId': 'OG011'}, {'value': '64400', 'spread': '1.75', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '2700', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '1130', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '5380', 'spread': '36.87', 'groupId': 'OG002'}, {'value': '2900', 'spread': '37.88', 'groupId': 'OG003'}, {'value': '4830', 'spread': '11.11', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG005'}, {'value': '5080', 'spread': '35.87', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG007'}, {'value': '10200', 'spread': '53.84', 'groupId': 'OG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG009'}, {'value': '13200', 'spread': '34.77', 'groupId': 'OG010'}, {'value': '15600', 'spread': '36.58', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)', 'description': 'AUC (inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.', 'unitOfMeasure': 'Hours*Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve From Time Zero to Tau (AUCtau) of LGX818: Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD (Capsules)', 'description': 'Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '50 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': '100 mg Encorafenib QD (Capsules)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '100 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG011', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG012', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '5360', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '2330', 'spread': '69.89', 'groupId': 'OG001'}, {'value': '7610', 'spread': '82.98', 'groupId': 'OG002'}, {'value': '5010', 'spread': '39.39', 'groupId': 'OG003'}, {'value': '9400', 'spread': '20.06', 'groupId': 'OG004'}, {'value': '3210', 'spread': '92.21', 'groupId': 'OG005'}, {'value': '9860', 'spread': '26.5', 'groupId': 'OG006'}, {'value': '4780', 'spread': '52.49', 'groupId': 'OG007'}, {'value': '20300', 'spread': '29.06', 'groupId': 'OG008'}, {'value': '8690', 'spread': '49.73', 'groupId': 'OG009'}, {'value': '32800', 'spread': '69.05', 'groupId': 'OG010'}, {'value': '31700', 'spread': '45.33', 'groupId': 'OG011'}, {'value': '63900', 'spread': '1.41', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '2660', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '1120', 'spread': '19.67', 'groupId': 'OG001'}, {'value': '5330', 'spread': '36.58', 'groupId': 'OG002'}, {'value': '2890', 'spread': '37.55', 'groupId': 'OG003'}, {'value': '4750', 'spread': '12.25', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG005'}, {'value': '5060', 'spread': '35.79', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG007'}, {'value': '10100', 'spread': '53.35', 'groupId': 'OG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG009'}, {'value': '13100', 'spread': '34.85', 'groupId': 'OG010'}, {'value': '15300', 'spread': '36.38', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)', 'unitOfMeasure': 'Hours*Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Elimination Half-life (t1/2) of LGX818: Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD (Capsules)', 'description': 'Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '50 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': '100 mg Encorafenib QD (Capsules)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '100 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG011', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG012', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000', 'lowerLimit': '4.38', 'upperLimit': '4.38'}, {'value': '3.77', 'groupId': 'OG001', 'lowerLimit': '3.57', 'upperLimit': '4.44'}, {'value': '3.47', 'groupId': 'OG002', 'lowerLimit': '3.38', 'upperLimit': '3.88'}, {'value': '3.7', 'groupId': 'OG003', 'lowerLimit': '3.32', 'upperLimit': '3.96'}, {'value': '3.66', 'groupId': 'OG004', 'lowerLimit': '3.09', 'upperLimit': '4.5'}, {'value': '2.82', 'groupId': 'OG005', 'lowerLimit': '2.02', 'upperLimit': '3.84'}, {'value': '3.3', 'groupId': 'OG006', 'lowerLimit': '2.56', 'upperLimit': '3.58'}, {'value': '2.53', 'groupId': 'OG007', 'lowerLimit': '1.69', 'upperLimit': '2.68'}, {'value': '3.42', 'groupId': 'OG008', 'lowerLimit': '2.84', 'upperLimit': '4.77'}, {'value': '2.16', 'groupId': 'OG009', 'lowerLimit': '2.16', 'upperLimit': '2.42'}, {'value': '2.92', 'groupId': 'OG010', 'lowerLimit': '2.32', 'upperLimit': '4.98'}, {'value': '3.32', 'groupId': 'OG011', 'lowerLimit': '3.28', 'upperLimit': '3.61'}, {'value': '3.25', 'groupId': 'OG012', 'lowerLimit': '2.96', 'upperLimit': '3.53'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '4.14', 'groupId': 'OG000', 'lowerLimit': '4.14', 'upperLimit': '4.14'}, {'value': '3.71', 'groupId': 'OG001', 'lowerLimit': '3.66', 'upperLimit': '5.63'}, {'value': '3.99', 'groupId': 'OG002', 'lowerLimit': '3.22', 'upperLimit': '4.05'}, {'value': '3.61', 'groupId': 'OG003', 'lowerLimit': '3.26', 'upperLimit': '4.1'}, {'value': '3.65', 'groupId': 'OG004', 'lowerLimit': '3.43', 'upperLimit': '7.47'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.13', 'groupId': 'OG006', 'lowerLimit': '2.95', 'upperLimit': '3.22'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.57', 'groupId': 'OG008', 'lowerLimit': '1.61', 'upperLimit': '4.06'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.19', 'groupId': 'OG010', 'lowerLimit': '2.82', 'upperLimit': '3.56'}, {'value': '3.25', 'groupId': 'OG011', 'lowerLimit': '2.96', 'upperLimit': '8'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG012', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)', 'description': 't1/2 was the time measured for the plasma concentration to decrease by one half. Terminal phase half-life expressed in hours (hr).', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Apparent Total Plasma Clearance of Drug (CL/F) of LGX818: Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD (Capsules)', 'description': 'Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '50 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': '100 mg Encorafenib QD (Capsules)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '100 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG011', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG012', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '9.14', 'spread': 'NA', 'comment': 'The geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '70.37', 'groupId': 'OG001'}, {'value': '13', 'spread': '83.44', 'groupId': 'OG002'}, {'value': '19.8', 'spread': '39.57', 'groupId': 'OG003'}, {'value': '15.8', 'spread': '20.11', 'groupId': 'OG004'}, {'value': '33.8', 'spread': '53.66', 'groupId': 'OG005'}, {'value': '20.2', 'spread': '26.24', 'groupId': 'OG006'}, {'value': '22.7', 'spread': '69.51', 'groupId': 'OG007'}, {'value': '15', 'spread': '33.36', 'groupId': 'OG008'}, {'value': '16.8', 'spread': '50', 'groupId': 'OG009'}, {'value': '13.6', 'spread': '70.34', 'groupId': 'OG010'}, {'value': '17.2', 'spread': '45.51', 'groupId': 'OG011'}, {'value': '10.9', 'spread': '1.75', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '18.8', 'spread': 'NA', 'comment': 'The geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '44.7', 'spread': '19.67', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '36.58', 'groupId': 'OG002'}, {'value': '34.6', 'spread': '37.55', 'groupId': 'OG003'}, {'value': '31.5', 'spread': '12.25', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG005'}, {'value': '39.5', 'spread': '35.79', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG007'}, {'value': '29.6', 'spread': '53.35', 'groupId': 'OG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG009'}, {'value': '34.3', 'spread': '34.85', 'groupId': 'OG010'}, {'value': '36', 'spread': '36.38', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)', 'unitOfMeasure': 'Liter/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F) of LGX818: Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD (Capsules)', 'description': 'Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '50 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': '100 mg Encorafenib QD (Capsules)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '100 mg Encorafenib QD (Microemulsion)', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG011', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG012', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '57.8', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '120', 'spread': '56.42', 'groupId': 'OG001'}, {'value': '67', 'spread': '79.38', 'groupId': 'OG002'}, {'value': '104', 'spread': '35.34', 'groupId': 'OG003'}, {'value': '84.5', 'spread': '28.15', 'groupId': 'OG004'}, {'value': '116', 'spread': '27.23', 'groupId': 'OG005'}, {'value': '91.9', 'spread': '39.62', 'groupId': 'OG006'}, {'value': '73.8', 'spread': '39.95', 'groupId': 'OG007'}, {'value': '76.5', 'spread': '33.65', 'groupId': 'OG008'}, {'value': '53.9', 'spread': '49.07', 'groupId': 'OG009'}, {'value': '60.5', 'spread': '53.31', 'groupId': 'OG010'}, {'value': '84.8', 'spread': '41.99', 'groupId': 'OG011'}, {'value': '50.7', 'spread': '10.87', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '112', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '274', 'spread': '7.68', 'groupId': 'OG001'}, {'value': '103', 'spread': '36.42', 'groupId': 'OG002'}, {'value': '182', 'spread': '33.22', 'groupId': 'OG003'}, {'value': '188', 'spread': '43.23', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG005'}, {'value': '177', 'spread': '31', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG007'}, {'value': '128', 'spread': '12.49', 'groupId': 'OG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG009'}, {'value': '157', 'spread': '38.55', 'groupId': 'OG010'}, {'value': '221', 'spread': '75.92', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Tumor Response Per RECIST Criteria- Dose Escalation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': '100 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity'}, {'id': 'OG002', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG005', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG006', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG007', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG008', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG009', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG010', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}]}]}, {'title': 'Progressive Disease (PD)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 556.1 weeks of treatment exposure)', 'description': 'Tumor response included: CR, PR, stable disease and disease progression (PD). CR=complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \\<10 mm. PR=at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \\>= 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least one dose of encorafenib.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration of LGX818: Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4310', 'spread': '31.6', 'groupId': 'OG000'}, {'value': '5650', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '7790', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '6580', 'spread': '34.24', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '1340', 'groupId': 'OG005'}, {'value': '8380', 'spread': '32.93', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1060', 'spread': '41.1', 'groupId': 'OG000'}, {'value': '5590', 'spread': '22.56', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '5650', 'spread': '79.98', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2050', 'spread': '43.71', 'groupId': 'OG000'}, {'value': '4960', 'spread': '32.64', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '1040', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG005'}, {'value': '5130', 'spread': '48.81', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Vz/F of LGX818: Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '79.1', 'spread': '29.82', 'groupId': 'OG000'}, {'value': '25.3', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '59.7', 'spread': '35.42', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '44.6', 'spread': '26.6', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '219', 'spread': '41.9', 'groupId': 'OG000'}, {'value': '66.1', 'spread': '23.07', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '70', 'spread': '40.28', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '243', 'spread': '79', 'groupId': 'OG000'}, {'value': '130', 'spread': '20.81', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '194', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG005'}, {'value': '110', 'spread': '32.51', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. 'Overall Number of Participants Analyzed' signifies number of participants with evaluable data for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Tmax of LGX818: Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000', 'lowerLimit': '1.95', 'upperLimit': '1.97'}, {'value': '2.08', 'groupId': 'OG001', 'lowerLimit': '2.08', 'upperLimit': '2.08'}, {'value': '3.97', 'groupId': 'OG002', 'lowerLimit': '3.97', 'upperLimit': '3.97'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '2.12'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG006', 'lowerLimit': '0.667', 'upperLimit': '4'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.92', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '1.98'}, {'value': '1.93', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '2.07'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG006', 'lowerLimit': '0.5', 'upperLimit': '2'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.88', 'upperLimit': '1.97'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '2.3'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG006', 'lowerLimit': '1.97', 'upperLimit': '2.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)', 'description': 'Tmax was the time required to reach the maximum plasma concentration (Cmax). First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in hours (hr).', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'AUCinf of LGX818: Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '18200', 'spread': '32.37', 'groupId': 'OG000'}, {'value': '70900', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '33300', 'spread': '39.98', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '54400', 'spread': '42.97', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4290', 'spread': '30.9', 'groupId': 'OG000'}, {'value': '16600', 'spread': '23.69', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '16400', 'spread': '34.68', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2050', 'spread': '43.71', 'groupId': 'OG000'}, {'value': '4960', 'spread': '32.64', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '1040', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG005'}, {'value': '17300', 'spread': '38.06', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)', 'description': 'AUC (inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.', 'unitOfMeasure': 'Hours*Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. 'Overall Number of Participants Analyzed' signifies number of participants with evaluable data for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'AUCtau of LGX818: Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '18100', 'spread': '32.22', 'groupId': 'OG000'}, {'value': '35300', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '69300', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '33200', 'spread': '39.86', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '54400', 'spread': '42.97', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4290', 'spread': '30.9', 'groupId': 'OG000'}, {'value': '16600', 'spread': '23.69', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '16400', 'spread': '34.67', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '7380', 'spread': '60.51', 'groupId': 'OG000'}, {'value': '17600', 'spread': '25.65', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '10400', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG005'}, {'value': '17300', 'spread': '37.9', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)', 'unitOfMeasure': 'hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 't1/2 of LGX818: Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3.36', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3.65'}, {'value': '4.04', 'groupId': 'OG001', 'lowerLimit': '4.04', 'upperLimit': '4.04'}, {'value': '4.14', 'groupId': 'OG002', 'lowerLimit': '4.14', 'upperLimit': '4.14'}, {'value': '3.07', 'groupId': 'OG003', 'lowerLimit': '2.61', 'upperLimit': '3.38'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.63', 'groupId': 'OG006', 'lowerLimit': '2.59', 'upperLimit': '6.44'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.41', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '2.47'}, {'value': '1.66', 'groupId': 'OG003', 'lowerLimit': '1.61', 'upperLimit': '1.81'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.76', 'groupId': 'OG006', 'lowerLimit': '1.62', 'upperLimit': '1.98'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4.33', 'groupId': 'OG000', 'lowerLimit': '3.47', 'upperLimit': '4.75'}, {'value': '3.37', 'groupId': 'OG003', 'lowerLimit': '2.87', 'upperLimit': '4.24'}, {'value': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.51', 'groupId': 'OG005', 'lowerLimit': '4.51', 'upperLimit': '4.51'}, {'value': '3.13', 'groupId': 'OG006', 'lowerLimit': '1.73', 'upperLimit': '4.42'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'CL/F of LGX818: Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '32.37', 'groupId': 'OG000'}, {'value': '4.23', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '13.5', 'spread': '39.98', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '8.27', 'spread': '42.97', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '70.1', 'spread': '30.98', 'groupId': 'OG000'}, {'value': '27.2', 'spread': '23.63', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '27.4', 'spread': '34.67', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '40.7', 'spread': '60.51', 'groupId': 'OG000'}, {'value': '25.6', 'spread': '25.65', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data could not be estimated as values were below limit of quantitation.', 'groupId': 'OG004'}, {'value': '29.9', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG005'}, {'value': '26', 'spread': '37.9', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)', 'unitOfMeasure': 'liter/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. 'Overall Number of Participants Analyzed' signifies number of participants with evaluable data for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Number of Participants According to BRAF V600 Mutation Status at Baseline: Dose Expansion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'categories': [{'title': 'V600E', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}, {'title': 'Others', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '(Baseline) last non-missing value prior to the first dose (Baseline)', 'description': 'Number of participants according to BRAF V600 mutation status as V600E (i.e., mutation of the BRAF gene in which valine \\[V\\] was substituted by glutamic acid \\[E\\] at amino acid 600) or other is reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least one dose of Encorafenib'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Tumor Response Per RECIST Criteria: Dose Expansion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}]}, {'title': 'Progressive Disease (PD)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'umor response included: CR, PR, stable disease and disease progression (PD). CR=complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \\<10 mm. PR=at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \\>= 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least one dose of encorafenib.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '50 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG001', 'title': '100 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG002', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG003', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG004', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG005', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG006', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG007', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG008', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG009', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG010', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG011', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG012', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG013', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG014', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'FG015', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'FG016', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'FG017', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}], 'periods': [{'title': 'Dose Escalation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'New anti-cancer therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}, {'title': 'Dose Expansion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'comment': 'Participants enrolled in dose expansion phase.', 'groupId': 'FG011', 'numSubjects': '9'}, {'comment': 'Participants enrolled in dose expansion phase.', 'groupId': 'FG012', 'numSubjects': '6'}, {'comment': 'Participants enrolled in dose expansion phase.', 'groupId': 'FG013', 'numSubjects': '2'}, {'comment': 'Participants enrolled in dose expansion phase.', 'groupId': 'FG014', 'numSubjects': '16'}, {'comment': 'Participants enrolled in dose expansion phase.', 'groupId': 'FG015', 'numSubjects': '2'}, {'comment': 'Participants enrolled in dose expansion phase.', 'groupId': 'FG016', 'numSubjects': '6'}, {'comment': 'Participants enrolled in dose expansion phase.', 'groupId': 'FG017', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '8'}, {'groupId': 'FG015', 'numSubjects': '2'}, {'groupId': 'FG016', 'numSubjects': '2'}, {'groupId': 'FG017', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '6'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '8'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '4'}, {'groupId': 'FG017', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '3'}, {'groupId': 'FG017', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '3'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}]}, {'type': 'New cancer therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 107 participants (54 in dose escalation and 53 in dose expansion) were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '16', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '12', 'groupId': 'BG017'}, {'value': '107', 'groupId': 'BG018'}]}], 'groups': [{'id': 'BG000', 'title': '50 mg of Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity'}, {'id': 'BG001', 'title': '100 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG002', 'title': '150 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG003', 'title': '75 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG004', 'title': '200 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG005', 'title': '100 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG006', 'title': '300 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG007', 'title': '150 mg Encorafenib BID', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG008', 'title': '450 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG009', 'title': '550 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG010', 'title': '700 mg Encorafenib QD', 'description': 'Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG011', 'title': 'Mel Naive 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG012', 'title': 'Mel Naive 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG013', 'title': 'Mel Pre-treated: 300 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG014', 'title': 'Mel Pre-treated: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.'}, {'id': 'BG015', 'title': 'Mel Stepwise: 450 mg Encorafenib', 'description': 'Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'BG016', 'title': 'Metastatic Colorectal Cancer: 300 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'BG017', 'title': 'Metastatic Colorectal Cancer: 450 mg Encorafenib', 'description': 'Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.'}, {'id': 'BG018', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}, {'title': 'Between 18 and 44 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '27', 'groupId': 'BG018'}]}, {'title': 'Between 45 and 64 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '4', 'groupId': 'BG016'}, {'value': '7', 'groupId': 'BG017'}, {'value': '51', 'groupId': 'BG018'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '5', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '29', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '13', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '3', 'groupId': 'BG016'}, {'value': '7', 'groupId': 'BG017'}, {'value': '48', 'groupId': 'BG018'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '3', 'groupId': 'BG016'}, {'value': '5', 'groupId': 'BG017'}, {'value': '59', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Caucasian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '16', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '12', 'groupId': 'BG017'}, {'value': '100', 'groupId': 'BG018'}]}, {'title': 'Others', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '7', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety set included all participants from the full analysis set (all participants who received at least one dose of encorafenib) who had at least one valid post-baseline safety assessment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2011-04-14', 'resultsFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2011-09-19', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-13', 'studyFirstPostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-Limiting Toxicity (DLT) During Dose Escalation Phase', 'timeFrame': 'Up to 28 days', 'description': 'DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: \\>=grade (G)3 neutropenia or thrombocytopenia for \\>7 days; G4 thrombocytopenia; febrile neutropenia; \\>=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (\\>=G3 for \\> 7 consecutive days or G4); \\>=G3 ALT or AST and \\>=G2 blood bilirubin; \\>=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for \\>7 consecutive days; \\>= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; \\>=G3 pancreatitis, rash/photosensitivity (G3 for \\> 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.'}, {'measure': 'Number of Participants With DLT During Dose Expansion Phase', 'timeFrame': 'Up to 28 days', 'description': 'DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: \\>=grade (G)3 neutropenia or thrombocytopenia for \\>7 days; G4 thrombocytopenia; febrile neutropenia; \\>=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (\\>=G3 for \\> 7 consecutive days or G4); \\>=G3 ALT or AST and \\>=G2 blood bilirubin; \\>=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for \\>7 consecutive days; \\>= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; \\>=G3 pancreatitis, rash/photosensitivity (G3 for \\> 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Dose Escalation Phase', 'timeFrame': 'From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure)', 'description': 'An AE was defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions. An SAE was defined as one of the following: fatal or life-threatening; resulted in significant disability/incapacity; congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization unless for routine treatment, elective or pre-planned treatment for a pre-existing condition, treatment on an emergency outpatient basis, social reasons and respite care in the absence of any deterioration in the participants general condition, any SAEs that were expected due to the condition being treated.'}, {'measure': 'Number of Participants With AEs and SAEs During Dose Expansion Phase', 'timeFrame': 'From start of study treatment until 30 days after last dose of study treatment (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'An AE was defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions. An SAE was defined as one of the following: fatal or life-threatening; resulted in significant disability/incapacity; congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization unless for routine treatment, elective or pre-planned treatment for a pre-existing condition, treatment on an emergency outpatient basis, social reasons and respite care in the absence of any deterioration in the participants general condition, any SAEs that were expected due to the condition being treated.'}, {'measure': 'Progression Free Survival (PFS): Dose Escalation Phase', 'timeFrame': 'From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 556.1 weeks of treatment exposure)', 'description': 'PFS was defined as time from date of first study treatment intake to date of first documented disease progression (PD) or death due to any cause. If a participant did not have an event, data censoring was done at the date of last adequate tumor assessment. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of greater than or equal to (\\>=) 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier method.'}, {'measure': 'PFS: Dose Expansion Phase', 'timeFrame': 'From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'PFS was defined as time from date of first study treatment intake to date of first documented PD or death due to any cause. If a participant did not have an event, data censoring was done at the date of last adequate tumor assessment. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of \\>= 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier method.'}, {'measure': 'Duration of Response (DOR): Dose Escalation Phase', 'timeFrame': 'From first observation of response until first time of PD or death due to any cause (Maximum of 556.1 weeks of treatment exposure)', 'description': 'DOR was defined as the time from first observation of response CR or partial response \\[PR\\]) to the first time of progression or death. CR was defined as complete disappearance of all target and non-target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\\<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \\>= 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.'}, {'measure': 'Time to Response (TTR): Dose Escalation Phase', 'timeFrame': 'From date of start of treatment until CR or PR or censoring date (maximum of 556.1 weeks of treatment exposure)', 'description': 'TTR was defined as the time from date of treatment until first documented response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \\<10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. Individual participant data have been reported for this outcome measure.'}, {'measure': 'DOR: Dose Expansion Phase', 'timeFrame': 'From first observation of response until first time of PD or death due to any cause (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'DOR was defined as the time from first observation of response (CR or PR\\] to the first time of progression or death. CR was defined as complete disappearance of all target and non-target lesions and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to (\\<10 mm. PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \\>= 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.'}, {'measure': 'TTR: Dose Expansion Phase', 'timeFrame': 'From date of start of treatment until CR or PR or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'TTR was defined as the time from date of treatment until first documented response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \\<10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. Individual participant data have been reported for this outcome measure.'}, {'measure': 'Overall Survival (OS): Dose Expansion Phase', 'timeFrame': 'From start of study treatment until date of death or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'Overall survival was defined as the time from the date of first study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.'}, {'measure': 'Maximum Observed Plasma Concentration of LGX818: Dose Escalation Phase', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)'}, {'measure': 'Time Point of Maximum Concentration (Tmax) of LGX818: Dose Escalation Phase', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of LGX818: Dose Escalation Phase', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)', 'description': 'AUC (inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to Tau (AUCtau) of LGX818: Dose Escalation Phase', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)'}, {'measure': 'Elimination Half-life (t1/2) of LGX818: Dose Escalation Phase', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)', 'description': 't1/2 was the time measured for the plasma concentration to decrease by one half. Terminal phase half-life expressed in hours (hr).'}, {'measure': 'Apparent Total Plasma Clearance of Drug (CL/F) of LGX818: Dose Escalation Phase', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of LGX818: Dose Escalation Phase', 'timeFrame': 'Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)'}, {'measure': 'Number of Participants According to Tumor Response Per RECIST Criteria- Dose Escalation', 'timeFrame': 'From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 556.1 weeks of treatment exposure)', 'description': 'Tumor response included: CR, PR, stable disease and disease progression (PD). CR=complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \\<10 mm. PR=at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \\>= 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.'}, {'measure': 'Maximum Observed Plasma Concentration of LGX818: Dose Expansion Phase', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)'}, {'measure': 'Vz/F of LGX818: Dose Expansion Phase', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)'}, {'measure': 'Tmax of LGX818: Dose Expansion Phase', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)', 'description': 'Tmax was the time required to reach the maximum plasma concentration (Cmax). First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in hours (hr).'}, {'measure': 'AUCinf of LGX818: Dose Expansion Phase', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)', 'description': 'AUC (inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.'}, {'measure': 'AUCtau of LGX818: Dose Expansion Phase', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)'}, {'measure': 't1/2 of LGX818: Dose Expansion Phase', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)'}, {'measure': 'CL/F of LGX818: Dose Expansion Phase', 'timeFrame': 'Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)'}, {'measure': 'Number of Participants According to BRAF V600 Mutation Status at Baseline: Dose Expansion', 'timeFrame': '(Baseline) last non-missing value prior to the first dose (Baseline)', 'description': 'Number of participants according to BRAF V600 mutation status as V600E (i.e., mutation of the BRAF gene in which valine \\[V\\] was substituted by glutamic acid \\[E\\] at amino acid 600) or other is reported in this outcome measure.'}, {'measure': 'Number of Participants According to Tumor Response Per RECIST Criteria: Dose Expansion', 'timeFrame': 'From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)', 'description': 'umor response included: CR, PR, stable disease and disease progression (PD). CR=complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \\<10 mm. PR=at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \\>= 5 mm, or appearance of \\>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BRAF mutant,', 'BRAF mutated,', 'melanoma,', 'metastatic,', 'advanced,', 'RAF kinase inhibitor', 'BRAF V600 mutation'], 'conditions': ['Melanoma and Metastatic Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor the dose escalation phase:\n\n1. Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer \\[AJCC\\]). For the dose expansion phase: (i) Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer \\[AJCC\\]), or (ii) confirmed diagnosis and non-resectable advanced metastatic colorectal cancer (mCRC) for which no further effective standard therapy exists.\n2. Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.\n3. Evidence of measurable disease\n\nExclusion Criteria:\n\n1. Previous therapy with a MEK inhibitor.\n2. Symptomatic or untreated leptomeningeal disease.\n3. Symptomatic or untreated brain metastasis.Patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging.\n4. Known acute or chronic pancreatitis.\n5. Clinically significant cardiac disease\n6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818\n7. Previous or concurrent malignancy. Exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.\n8. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\\> 5 mIU/mL).\n9. History of thromboembolic or cerebrovascular events within the last 6 months\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01436656', 'briefTitle': 'A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LGX818 in Adult Patients With Locally Advanced or Metastatic BRAF Mutant Melanoma', 'orgStudyIdInfo': {'id': 'CLGX818X2101'}, 'secondaryIdInfos': [{'id': 'C4221010', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2011-000556-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LGX818 - Dose escalation', 'interventionNames': ['Drug: LGX818']}, {'type': 'EXPERIMENTAL', 'label': 'LGX818 - Dose Expansion at MTD or RP2D', 'interventionNames': ['Drug: LGX818']}], 'interventions': [{'name': 'LGX818', 'type': 'DRUG', 'armGroupLabels': ['LGX818 - Dose Expansion at MTD or RP2D', 'LGX818 - Dose escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Western Sydney Local Health District', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital- Redbank Rd', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '31059 Cedex 9', 'city': 'Toulouse', 'state': 'Haute-garonne', 'country': 'France', 'facility': 'EDOG - Institut Claudius Regaud - PPDS', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94800', 'city': 'Villejuif', 'state': 'ILE de France - VAL de Marne (94)', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '94800', 'city': 'Villejuif', 'state': 'VAL DE Marne', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '94805', 'city': 'Villejuif', 'state': 'Val-de-marne', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital'}, {'zip': '00424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo Myeloma Center - PPDS', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '08036', 'city': 'Badalona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital General Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron - PPDS", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron - PPDS", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario HM Sanchinarro_CIOCC', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'START MADRID_Hospital Universitario HM Sanchinarro - CIOCC', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '07000', 'city': 'Chur', 'state': 'Graubünden (DE)', 'country': 'Switzerland', 'facility': 'Kantonsspital Graubünden', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universität Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}