Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2026-02-06 @ 2:19 AM
Study NCT ID:
NCT01740427
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2012-11-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500026', 'term': 'palbociclib'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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 publications 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 the date of randomization up to 28 days after last dose of study medication (final analysis till study completion, approximately up to 10.51 years)', 'description': 'Same event may appear as non-SAE and SAE but are distinct events. Event may be an SAE in 1 participant and non-SAE in other, or participant may have both non-SAE and SAE. AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.', 'otherNumAtRisk': 444, 'deathsNumAtRisk': 444, 'otherNumAffected': 435, 'seriousNumAtRisk': 444, 'deathsNumAffected': 16, 'seriousNumAffected': 125}, {'id': 'EG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 209, 'seriousNumAtRisk': 222, 'deathsNumAffected': 6, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 125}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 308}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 169}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 187}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 89}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 52}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 41}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 62}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 27}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 30}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 10}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 48}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 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unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ovarian germ cell teratoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': "Bell's palsy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cauda equina syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Thrombotic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Organic brain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Stag horn calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Breast haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Uterovaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tracheomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'comment': 'The value was not available because there was not enough disease progression events in the treatment group at the time of analysis, due to drug benefit.', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': 'NA'}, {'value': '14.5', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '17.1'}]}]}], 'analyses': [{'pValue': '<0.000001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.576', 'ciLowerLimit': '0.463', 'ciUpperLimit': '0.718', 'pValueComment': '1-sided p-value from the stratified log-rank test.', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date to date of first documentation of progression or death (up to approximately 2.5 years)', 'description': 'PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population or full analysis set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Objective Response as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000', 'lowerLimit': '41.7', 'upperLimit': '51.2'}, {'value': '38.3', 'groupId': 'OG001', 'lowerLimit': '31.9', 'upperLimit': '45.0'}]}]}], 'analyses': [{'pValue': '0.0224', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.428', 'ciLowerLimit': '1.008', 'ciUpperLimit': '2.030', 'pValueComment': '1-sided p-value is from exact test.', 'groupDescription': 'Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until end of treatment (up to approximately 2.5 years)', 'description': 'Objective Response (OR) defined as overall complete response (CR) or partial response (PR) according to RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \\<10mm). PR: \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Objective Response: Participants With Measurable Disease at Baseline as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000', 'lowerLimit': '55.2', 'upperLimit': '65.9'}, {'value': '49.1', 'groupId': 'OG001', 'lowerLimit': '41.4', 'upperLimit': '56.9'}]}]}], 'analyses': [{'pValue': '0.0090', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.594', 'ciLowerLimit': '1.080', 'ciUpperLimit': '2.347', 'pValueComment': '1-sided p-value is from exact test.', 'groupDescription': 'Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until end of treatment (up to approximately 2.5 years)', 'description': 'The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \\<10mm). PR: \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had measurable disease at baseline.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '28.0'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '22.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until end of treatment (up to approximately 2.5 years)', 'description': 'DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date will be used. DR was calculated as \\[the date response ended (i.e. date of PD or death) - first CR or PR date + 1)\\]/30.4. DR would only be calculated for the subgroup of participants with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \\<10mm). PR: \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had tumor response with CR or PR during study.'}, {'type': 'SECONDARY', 'title': 'Disease Control (DC)/Clinical Benefit Response (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000', 'lowerLimit': '82.2', 'upperLimit': '88.9'}, {'value': '71.2', 'groupId': 'OG001', 'lowerLimit': '64.7', 'upperLimit': '77.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.451', 'ciLowerLimit': '1.619', 'ciUpperLimit': '3.722', 'pValueComment': '1-sided p-value is from exact test.', 'groupDescription': 'Stratified analysis: Stratified by disease site (visceral, non-visceral) per randomization.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until end of treatment (up to approximately 2.5 years)', 'description': 'DC is defined as overall CR, PR, or stable disease (SD) \\>=24 weeks according to RECIST version 1.1. Disease Control Rate (DCR) is defined as participants with CR, PR, or SD \\>=24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD\\>=24 weeks, or who died, progressed, or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD\\>=24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \\<10mm). PR: \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'title': 'ER Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.9', 'comment': 'Not reached; insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '22.2', 'upperLimit': 'NA'}, {'value': '16.3', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '19.1'}]}]}, {'title': 'ER Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '22.0'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '11.1'}]}]}, {'title': 'Rb Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '21.4', 'upperLimit': '25.7'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '16.5'}]}]}, {'title': 'Rb Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not reached; insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': 'NA'}, {'value': '18.5', 'comment': 'Not reached; insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': 'NA'}]}]}, {'title': 'Cyclin D1 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '27.6'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '16.8'}]}]}, {'title': 'Cyclin D1 Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '23.9'}, {'value': '8.1', 'comment': 'Not reached; insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': 'NA'}]}]}, {'title': 'p16 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.8', 'comment': 'Not reached; insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': 'NA'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '16.8'}]}]}, {'title': 'p16 Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '24.9'}, {'value': '13.8', 'comment': 'Not reached; insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': 'NA'}]}]}, {'title': 'p16 H-Score<175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '19.6', 'upperLimit': '25.7'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '16.8'}]}]}, {'title': 'p16 H-Score>=175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.2', 'comment': 'Not reached; insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': 'NA'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '19.1'}]}]}, {'title': 'Ki67 <=20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.6', 'comment': 'Not reached; insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '24.2', 'upperLimit': 'NA'}, {'value': '16.8', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '22.0'}]}]}, {'title': 'Ki67 >20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '22.0'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '13.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.571', 'ciLowerLimit': '0.443', 'ciUpperLimit': '0.737', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for ER positive', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.405', 'ciLowerLimit': '0.218', 'ciUpperLimit': '0.751', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for ER Negative', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.531', 'ciLowerLimit': '0.416', 'ciUpperLimit': '0.680', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for Rb Positive', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3237', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.675', 'ciLowerLimit': '0.308', 'ciUpperLimit': '1.481', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for Rb Negative', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.555', 'ciLowerLimit': '0.437', 'ciUpperLimit': '0.705', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for Cyclin D1 Positive', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9964', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.997', 'ciLowerLimit': '0.287', 'ciUpperLimit': '3.461', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for Cyclin D1 Negative', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.518', 'ciLowerLimit': '0.400', 'ciUpperLimit': '0.670', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for p16 Positive', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.731', 'ciLowerLimit': '0.392', 'ciUpperLimit': '1.364', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for p16 Negative', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.581', 'ciLowerLimit': '0.455', 'ciUpperLimit': '0.742', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for p16 HScore\\<175', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.255', 'ciLowerLimit': '0.100', 'ciUpperLimit': '0.650', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for p16 HScore\\>=175', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.530', 'ciLowerLimit': '0.379', 'ciUpperLimit': '0.742', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for Ki67 \\<=20%', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.569', 'ciLowerLimit': '0.409', 'ciUpperLimit': '0.791', 'estimateComment': 'Unstratified Cox proportional hazards model was used.', 'groupDescription': 'Statistical analysis for Ki67 \\>20%', 'statisticalMethod': 'Unstratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until end of treatment (up to approximately 24 Months)', 'description': 'PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Positive is defined as H-Score \\>=1 and negative as H-Score \\<1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)\\*0 + (% at 1+)\\*1 + (% at 2+)\\*2 + (% at 3+)\\*3. H-Score values range from 0 to 300. ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized. Here "Number Analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Corrected QT Interval (QTc) Time-Matched Change From Baseline on Cycle 1 Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'title': 'QTcS at 0 hour', 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '-1.67', 'upperLimit': '3.26'}, {'value': '2.95', 'groupId': 'OG001', 'lowerLimit': '-0.19', 'upperLimit': '6.10'}]}]}, {'title': 'QTcS at 2 hour', 'categories': [{'measurements': [{'value': '3.32', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '5.85'}, {'value': '1.65', 'groupId': 'OG001', 'lowerLimit': '-1.48', 'upperLimit': '4.78'}]}]}, {'title': 'QTcS at 4 hour', 'categories': [{'measurements': [{'value': '2.76', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '5.30'}, {'value': '1.74', 'groupId': 'OG001', 'lowerLimit': '-1.39', 'upperLimit': '4.87'}]}]}, {'title': 'QTcS at 6 hour', 'categories': [{'measurements': [{'value': '4.49', 'groupId': 'OG000', 'lowerLimit': '1.96', 'upperLimit': '7.02'}, {'value': '0.72', 'groupId': 'OG001', 'lowerLimit': '-2.41', 'upperLimit': '3.85'}]}]}, {'title': 'QTcS at 8 hour', 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '3.48'}, {'value': '3.14', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '6.27'}]}]}, {'title': 'QTcF at 0 hour', 'categories': [{'measurements': [{'value': '1.10', 'groupId': 'OG000', 'lowerLimit': '-1.39', 'upperLimit': '3.58'}, {'value': '3.06', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '6.23'}]}]}, {'title': 'QTcF at 2 hour', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '6.23'}, {'value': '1.73', 'groupId': 'OG001', 'lowerLimit': '-1.43', 'upperLimit': '4.88'}]}]}, {'title': 'QTcF at 4 hour', 'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000', 'lowerLimit': '0.31', 'upperLimit': '5.41'}, {'value': '1.54', 'groupId': 'OG001', 'lowerLimit': '-1.62', 'upperLimit': '4.70'}]}]}, {'title': 'QTcF at 6 hour', 'categories': [{'measurements': [{'value': '4.57', 'groupId': 'OG000', 'lowerLimit': '2.01', 'upperLimit': '7.12'}, {'value': '0.71', 'groupId': 'OG001', 'lowerLimit': '-2.44', 'upperLimit': '3.87'}]}]}, {'title': 'QTcF at 8 hour', 'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '-1.36', 'upperLimit': '3.77'}, {'value': '2.84', 'groupId': 'OG001', 'lowerLimit': '-0.31', 'upperLimit': '6.00'}]}]}, {'title': 'QTcB at 0 hour', 'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-2.83', 'upperLimit': '2.61'}, {'value': '2.78', 'groupId': 'OG001', 'lowerLimit': '-0.69', 'upperLimit': '6.25'}]}]}, {'title': 'QTcB at 2 hour', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '-1.34', 'upperLimit': '4.25'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '-2.63', 'upperLimit': '4.28'}]}]}, {'title': 'QTcB at 4 hour', 'categories': [{'measurements': [{'value': '2.58', 'groupId': 'OG000', 'lowerLimit': '-0.22', 'upperLimit': '5.38'}, {'value': '2.47', 'groupId': 'OG001', 'lowerLimit': '-0.98', 'upperLimit': '5.92'}]}]}, {'title': 'QTcB at 6 hour', 'categories': [{'measurements': [{'value': '4.03', 'groupId': 'OG000', 'lowerLimit': '1.24', 'upperLimit': '6.83'}, {'value': '0.53', 'groupId': 'OG001', 'lowerLimit': '-2.92', 'upperLimit': '3.99'}]}]}, {'title': 'QTcB at 8 hour', 'categories': [{'measurements': [{'value': '-0.17', 'groupId': 'OG000', 'lowerLimit': '-2.98', 'upperLimit': '2.64'}, {'value': '4.14', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '7.59'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population.", 'unitOfMeasure': 'msec', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'QTc analysis set is a subset of as treated (AT) population who were in Group 1; their QTc was used to study the effect of palbociclib on QT interval via serial triplicate ECGs with PK draws; and who had \\>= 1 pair of time-matched Day 0 and palbociclib postdose (Cycle1 Day14) measurements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Corrected QT Interval (QTc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'title': 'Maximum QTcS <450 msec', 'categories': [{'measurements': [{'value': '80.5', 'groupId': 'OG000'}, {'value': '85.9', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcS 450-<480 msec', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcS 480-<500 msec', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcS >=500 msec', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcF <450 msec', 'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000'}, {'value': '89.5', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcF 450-<480 msec', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcF 480-<500 msec', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcF >=500 msec', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcB <450 msec', 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000'}, {'value': '69.1', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcB 450-<480 msec', 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcB 480-<500 msec', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcB >=500 msec', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcS Change <30 msec', 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000'}, {'value': '94.5', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcS 30<=Change <60 msec', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcS Change>=60 msec', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcF Change <30 msec', 'categories': [{'measurements': [{'value': '91.6', 'groupId': 'OG000'}, {'value': '93.6', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcF 30<=Change <60 msec', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcF Change>=60 msec', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcB Change <30 msec', 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}, {'value': '91.4', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcB 30<=Change <60 msec', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcB Change>=60 msec', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10 (ECGs beyond Cycle 10 were performed as clinically indicated)', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The AT population or safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.'}, {'type': 'SECONDARY', 'title': 'Observed Plasma Trough Concentration (Ctrough) at Steady-State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'title': 'Cycle 1 Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.1', 'spread': '59', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.2', 'spread': '82', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hour (predose) on Day 14 of cycles 1 and 2', 'description': 'Summary of plasma palbociclib within-participant mean steady-state trough concentrations.', 'unitOfMeasure': 'Nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set was a subset of AT participants, who were treated with Palbociclib and had at least one measured plasma concentration. Here "Number Analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.014', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '-0.010', 'groupId': 'OG001', 'lowerLimit': '-0.03', 'upperLimit': '0.01'}]}]}], 'analyses': [{'pValue': '0.0925', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.023', 'ciLowerLimit': '-0.004', 'ciUpperLimit': '0.051', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline up to 2.5 years', 'description': 'The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.106', 'groupId': 'OG000', 'lowerLimit': '-1.42', 'upperLimit': '1.21'}, {'value': '0.219', 'groupId': 'OG001', 'lowerLimit': '-1.68', 'upperLimit': '2.12'}]}]}], 'analyses': [{'pValue': '0.7822', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.325', 'ciLowerLimit': '-2.63', 'ciUpperLimit': '1.98', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline up to 2.5 years', 'description': "FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs): All Causalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'title': 'Participants with AEs', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '96.4', 'groupId': 'OG001'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Grade 3 or 4 AEs', 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000'}, {'value': '30.2', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Grade 5 AEs', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Permanently discontinued study due to AEs', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Permanently disc. palbociclib/placebo due to AEs', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Permanently discontinued letrozole due to AEs', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Temporarily disc. palbociclib/placebo due to AEs', 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}]}]}, {'title': 'Temporarily discontinued letrozole due to AEs', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'With palbociclib/placebo dose reduction due to AEs', 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization up to 28 days after last dose of study drug (final analysis till study completion, approximately up to 10.51 years)', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization; resulted in persistent or significant disability or in congenital anomaly/birth defect. TEAE were events that occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Severity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening and Grade 5 = death related to AE. Discontinuation included permanent, temporary discontinuation and dose reduction due to AEs.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS): Primary Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000', 'lowerLimit': '49.8', 'upperLimit': '60.8'}, {'value': '51.2', 'groupId': 'OG001', 'lowerLimit': '43.7', 'upperLimit': '58.9'}]}]}], 'analyses': [{'pValue': '0.337750', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.956', 'ciLowerLimit': '0.777', 'ciUpperLimit': '1.177', 'pValueComment': '1-sided p-value from the stratified log-rank test.', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)', 'description': 'OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive. Data for this outcome measure was reported at primary analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS): Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '49.8', 'upperLimit': '59.2'}, {'value': '49.8', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '56.4'}]}]}], 'analyses': [{'pValue': '0.208706', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.921', 'ciLowerLimit': '0.755', 'ciUpperLimit': '1.124', 'pValueComment': '1-sided p-value from the stratified log-rank test.', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until death due to any cause or censored (final analysis till study completion, approximately up to 10.51 years)', 'description': 'OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive. Data for this outcome measure was reported at final analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Survival Probability at 1 Year, 2 Year and 3 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'title': '1 year survival probability', 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000', 'lowerLimit': '89.8', 'upperLimit': '94.7'}, {'value': '94.9', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '97.2'}]}]}, {'title': '2 year survival probability', 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '74.1', 'upperLimit': '82.0'}, {'value': '82.5', 'groupId': 'OG001', 'lowerLimit': '76.6', 'upperLimit': '87.0'}]}]}, {'title': '3 year survival probability', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000', 'lowerLimit': '65.1', 'upperLimit': '73.9'}, {'value': '65.0', 'groupId': 'OG001', 'lowerLimit': '58.0', 'upperLimit': '71.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 2 and 3 years after randomization', 'description': 'One, two or three-year survival probability was defined as the probability of survival 1 year, 2 or 3 years after the date of randomization. The survival probability was estimated using the Kaplan-Meier method and 2-sided 95% confidence interval (CI) was calculated using the product limit method.', 'unitOfMeasure': 'Percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'classes': [{'title': 'Anemia: Grade 1-2', 'categories': [{'measurements': [{'value': '328', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Anemia: Grade 3', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Increased: Grade 1-2', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Increased: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils (Absolute): Grade 1-2', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils (Absolute): Grade 3', 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils (Absolute): Grade 4', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 1-2', 'categories': [{'measurements': [{'value': '289', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 1-2', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 3', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT: Grade 1-2', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'ALT: Grade 3', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT: Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase: Grade 1-2', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase: Grade 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST: Grade 1-2', 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'AST: Grade 3', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (Total): Grade 1-2', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (Total): Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 1-2', 'categories': [{'measurements': [{'value': '418', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grade 1-2', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 1-2', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypermagnesemia: Grade 1-2', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Hypermagnesemia: Grade 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hypermagnesemia: Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grade 1-2', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grade 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypoalbuminemia: Grade 1-2', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Hypoalbuminemia: Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 1-2', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grade 1-2', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grade 3', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypomagnesemia: Grade 1-2', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Hypomagnesemia: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypomagnesemia: Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grade 1-2', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grade 3', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization up to 28 days after last dose of study drug (assessed up to analysis date of 15-Nov-2021, approximately 8.7 years)', 'description': 'Laboratory abnormalities included anemia, hemoglobin increased, neutrophils (absolute), platelets, white blood cells, alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total), creatinine, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia and hyponatremia. Laboratory abnormalities were graded by CTCAE version (v) 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life-threatening. Categories with at least 1 non-zero data values are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'FG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '444'}, {'groupId': 'FG001', 'numSubjects': '222'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '444'}, {'groupId': 'FG001', 'numSubjects': '222'}]}], 'dropWithdraws': [{'type': 'Objective Progression or Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '286'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Global Deterioration of Health Status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Participant Refused Continued Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Unspecified reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 666 participants were randomized at 239 centers in 19 countries.', 'preAssignmentDetails': 'The study consisted of a screening visit within 28 days before randomization, an active treatment phase, divided in cycles of 28 days each, and a post-treatment follow-up period during which survival and new anti-cancer therapy information was collected every 6 months (±7 days) from the last dose of study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '666', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Palbociclib Plus Letrozole', 'description': 'Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'BG001', 'title': 'Placebo Plus Letrozole', 'description': 'Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '444', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '666', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-21', 'size': 14577925, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-21T13:41', 'hasProtocol': True}, {'date': '2017-01-30', 'size': 11391533, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-21T13:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 666}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2012-11-26', 'resultsFirstSubmitDate': '2016-10-21', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-16', 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) as Assessed by the Investigator', 'timeFrame': 'From randomization date to date of first documentation of progression or death (up to approximately 2.5 years)', 'description': 'PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.'}], 'secondaryOutcomes': [{'measure': 'Objective Response as Assessed by the Investigator', 'timeFrame': 'From randomization until end of treatment (up to approximately 2.5 years)', 'description': 'Objective Response (OR) defined as overall complete response (CR) or partial response (PR) according to RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \\<10mm). PR: \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.'}, {'measure': 'Objective Response: Participants With Measurable Disease at Baseline as Assessed by the Investigator', 'timeFrame': 'From randomization until end of treatment (up to approximately 2.5 years)', 'description': 'The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \\<10mm). PR: \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'From randomization until end of treatment (up to approximately 2.5 years)', 'description': 'DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date will be used. DR was calculated as \\[the date response ended (i.e. date of PD or death) - first CR or PR date + 1)\\]/30.4. DR would only be calculated for the subgroup of participants with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \\<10mm). PR: \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.'}, {'measure': 'Disease Control (DC)/Clinical Benefit Response (CBR)', 'timeFrame': 'From randomization until end of treatment (up to approximately 2.5 years)', 'description': 'DC is defined as overall CR, PR, or stable disease (SD) \\>=24 weeks according to RECIST version 1.1. Disease Control Rate (DCR) is defined as participants with CR, PR, or SD \\>=24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD\\>=24 weeks, or who died, progressed, or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD\\>=24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \\<10mm). PR: \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression.'}, {'measure': 'PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)', 'timeFrame': 'From randomization until end of treatment (up to approximately 24 Months)', 'description': 'PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Positive is defined as H-Score \\>=1 and negative as H-Score \\<1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)\\*0 + (% at 1+)\\*1 + (% at 2+)\\*2 + (% at 3+)\\*3. H-Score values range from 0 to 300. ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.'}, {'measure': 'Corrected QT Interval (QTc) Time-Matched Change From Baseline on Cycle 1 Day 14', 'timeFrame': 'Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population."}, {'measure': 'Percentage of Participants With Corrected QT Interval (QTc)', 'timeFrame': 'For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10 (ECGs beyond Cycle 10 were performed as clinically indicated)', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population."}, {'measure': 'Observed Plasma Trough Concentration (Ctrough) at Steady-State', 'timeFrame': '0 hour (predose) on Day 14 of cycles 1 and 2', 'description': 'Summary of plasma palbociclib within-participant mean steady-state trough concentrations.'}, {'measure': 'Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index', 'timeFrame': 'From Baseline up to 2.5 years', 'description': 'The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).'}, {'measure': 'Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)', 'timeFrame': 'From Baseline up to 2.5 years', 'description': "FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best."}, {'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs): All Causalities', 'timeFrame': 'From date of randomization up to 28 days after last dose of study drug (final analysis till study completion, approximately up to 10.51 years)', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization; resulted in persistent or significant disability or in congenital anomaly/birth defect. TEAE were events that occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Severity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening and Grade 5 = death related to AE. Discontinuation included permanent, temporary discontinuation and dose reduction due to AEs.'}, {'measure': 'Overall Survival (OS): Primary Analysis', 'timeFrame': 'From date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)', 'description': 'OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive. Data for this outcome measure was reported at primary analysis.'}, {'measure': 'Overall Survival (OS): Final Analysis', 'timeFrame': 'From date of randomization until death due to any cause or censored (final analysis till study completion, approximately up to 10.51 years)', 'description': 'OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive. Data for this outcome measure was reported at final analysis.'}, {'measure': 'Survival Probability at 1 Year, 2 Year and 3 Year', 'timeFrame': '1, 2 and 3 years after randomization', 'description': 'One, two or three-year survival probability was defined as the probability of survival 1 year, 2 or 3 years after the date of randomization. The survival probability was estimated using the Kaplan-Meier method and 2-sided 95% confidence interval (CI) was calculated using the product limit method.'}, {'measure': 'Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade', 'timeFrame': 'From randomization up to 28 days after last dose of study drug (assessed up to analysis date of 15-Nov-2021, approximately 8.7 years)', 'description': 'Laboratory abnormalities included anemia, hemoglobin increased, neutrophils (absolute), platelets, white blood cells, alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total), creatinine, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia and hyponatremia. Laboratory abnormalities were graded by CTCAE version (v) 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life-threatening. Categories with at least 1 non-zero data values are reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer', 'postmenopausal women', 'estrogen-receptor positive', 'HER2 negative', 'locoregionally recurrent', 'metastatic', 'Palbociclib (PD-0332991)', 'PALOMA-2'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '38951507', 'type': 'DERIVED', 'citation': 'Cheang MCU, Rimawi M, Johnston S, Jacobs SA, Bliss J, Pogue-Geile K, Kilburn L, Zhu Z, Schuster EF, Xiao H, Swaim L, Deng S, Lu DR, Gauthier E, Tursi J, Slamon DJ, Rugo HS, Finn RS, Liu Y. Effect of cross-platform gene-expression, computational methods on breast cancer subtyping in PALOMA-2 and PALLET studies. 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Epub 2018 Mar 9.'}, {'pmid': '29360932', 'type': 'DERIVED', 'citation': 'Rugo HS, Dieras V, Gelmon KA, Finn RS, Slamon DJ, Martin M, Neven P, Shparyk Y, Mori A, Lu DR, Bhattacharyya H, Bartlett CHUANG, Iyer S, Johnston S, Ettl J, Harbeck N. Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial. Ann Oncol. 2018 Apr 1;29(4):888-894. doi: 10.1093/annonc/mdy012.'}, {'pmid': '29342248', 'type': 'DERIVED', 'citation': 'Turner NC, Finn RS, Martin M, Im SA, DeMichele A, Ettl J, Dieras V, Moulder S, Lipatov O, Colleoni M, Cristofanilli M, Lu DR, Mori A, Giorgetti C, Iyer S, Bartlett CH, Gelmon KA. Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. Ann Oncol. 2018 Mar 1;29(3):669-680. doi: 10.1093/annonc/mdx797.'}, {'pmid': '27959613', 'type': 'DERIVED', 'citation': 'Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.'}], 'seeAlsoLinks': [{'url': 'https://www.pmiform.com/clinical-trial-info-request?StudyID=A5481008', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.\n* Confirmed diagnosis of ER positive breast cancer\n* No prior systemic anti-cancer therapy for advanced ER+ disease.\n* Postmenopausal women\n* Measurable disease as per Response Evaluation Criterion in Solid Tumors \\[RECIST\\] or bone-only disease\n* Eastern Cooperative Oncology Group \\[ECOG\\] 0-2\n* Adequate organ and marrow function\n* Patient must agree to provide tumor tissue\n\nExclusion Criteria:\n\n* Confirmed diagnosis of HER2 positive disease\n* Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term\n* Known uncontrolled or symptomatic CNS metastases\n* Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.\n* Prior treatment with any CDK 4/6 inhibitor.'}, 'identificationModule': {'nctId': 'NCT01740427', 'briefTitle': 'A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE', 'orgStudyIdInfo': {'id': 'A5481008'}, 'secondaryIdInfos': [{'id': '2012-004601-27', 'type': 'EUDRACT_NUMBER'}, {'id': 'PALMOA-2', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': 'PALOMA-2', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD-0332991 + Letrozole', 'description': 'PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).', 'interventionNames': ['Drug: PD-0332991', 'Drug: Letrozole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Letrozole', 'description': 'Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).', 'interventionNames': ['Drug: Placebo', 'Drug: Letrozole']}], 'interventions': [{'name': 'PD-0332991', 'type': 'DRUG', 'description': 'PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment', 'armGroupLabels': ['PD-0332991 + Letrozole']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Letrozole, 2.5mg, orally once daily (continuously)', 'armGroupLabels': ['PD-0332991 + Letrozole']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment', 'armGroupLabels': ['Placebo + Letrozole']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Letrozole, 2.5mg, orally once daily (continuously)', 'armGroupLabels': ['Placebo + Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Beverly Hills Cancer Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Heritage Healthcare', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Hematology/Oncology Medical Group', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92604', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology/ Oncology- Irvine', 'geoPoint': {'lat': 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