Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT01386658
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2011-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054179', 'term': 'Angioedemas, Hereditary'}], 'ancestors': [{'id': 'D000799', 'term': 'Angioedema'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000081208', 'term': 'Hereditary Complement Deficiency Diseases'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C065679', 'term': 'icatibant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study drug administration up to 187 days', 'eventGroups': [{'id': 'EG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pubertal/Post-pubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 8, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Overall', 'description': 'Participants received a single subcutaneous(SC) injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region. Pubertal/postpubertal participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 12, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Epiphyseal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nitrite urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal: With Acute Attack', 'description': 'Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG002', 'title': 'Pubertal/Postpubertal: Without Acute Attack', 'description': 'Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '0.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Time to peak concentration (Tmax) of a single SC dose of icatibant was reported.', 'unitOfMeasure': 'Hour (h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal: With Acute Attack', 'description': 'Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG002', 'title': 'Pubertal/Postpubertal: Without Acute Attack', 'description': 'Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}], 'classes': [{'categories': [{'measurements': [{'value': '659', 'spread': '158', 'groupId': 'OG000'}, {'value': '805', 'spread': '125', 'groupId': 'OG001'}, {'value': '761', 'spread': '133', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Maximum plasma concentration (Cmax) of a single SC dose of icatibant was reported.', 'unitOfMeasure': 'Nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal: With Acute Attack', 'description': 'Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG002', 'title': 'Pubertal/Postpubertal: Without Acute Attack', 'description': 'Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '3.42', 'groupId': 'OG001'}, {'value': '19.3', 'spread': '4.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Total plasma clearance (CL/F) of a single SC dose of icatibant was reported.', 'unitOfMeasure': 'Milliliters per minute (mL/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4) of a Single Subcutaneous (SC) Dose of Icatibant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal: With Acute Attack', 'description': 'Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG002', 'title': 'Pubertal/Postpubertal: Without Acute Attack', 'description': 'Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}], 'classes': [{'categories': [{'measurements': [{'value': '1241', 'spread': '319', 'groupId': 'OG000'}, {'value': '1448', 'spread': '304', 'groupId': 'OG001'}, {'value': '1335', 'spread': '211', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, and 4 hours post-dose on Day 1', 'description': 'Area under the plasma concentration-time curve from time zero to 4 hours post-dose (AUC0-4) of a single SC dose of icatibant was reported.', 'unitOfMeasure': 'Hour*nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours Post-dose (AUC0-t) of a Single Subcutaneous (SC) Dose of Icatibant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal: With Acute Attack', 'description': 'Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG002', 'title': 'Pubertal/Postpubertal: Without Acute Attack', 'description': 'Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}], 'classes': [{'categories': [{'measurements': [{'value': '1289', 'spread': '325', 'groupId': 'OG000'}, {'value': '1573', 'spread': '372', 'groupId': 'OG001'}, {'value': '1398', 'spread': '225', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Area under the plasma concentration-time curve from time zero to 6 hours post-dose (AUC0-t) of a single SC dose of icatibant was reported.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of a Single Subcutaneous (SC) Dose of Icatibant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal: With Acute Attack', 'description': 'Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG002', 'title': 'Pubertal/Postpubertal: Without Acute Attack', 'description': 'Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}], 'classes': [{'categories': [{'measurements': [{'value': '1243', 'spread': '244', 'groupId': 'OG000'}, {'value': '1710', 'spread': '569', 'groupId': 'OG001'}, {'value': '1416', 'spread': '229', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of a single SC dose of icatibant was reported.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Volume of Distribution (Vz/F) of a Single Subcutaneous (SC) Dose of Icatibant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal: With Acute Attack', 'description': 'Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG002', 'title': 'Pubertal/Postpubertal: Without Acute Attack', 'description': 'Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'spread': '5.28', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '25.4', 'spread': '8.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Volume of distribution (Vz/F) of a single SC dose of icatibant was reported.', 'unitOfMeasure': 'Liters (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Elimination Half-life (t1/2) of a Single Subcutaneous (SC) Dose of Icatibant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal: With Acute Attack', 'description': 'Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG002', 'title': 'Pubertal/Postpubertal: Without Acute Attack', 'description': 'Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.80', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '0.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Elimination half-life (t1/2) of a single SC dose of icatibant was reported.', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Changes in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-dose up to 97 days post-dose', 'description': 'Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants who reported clinically significant changes in vital signs were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who were treated with icatibant at least once during the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 - 8 hours post-dose on Day 1', 'description': 'A standard 12-lead ECG was performed after 10 minutes at rest when the participant was seated or supine following treatment. The number of participants who reported clinically significant changes in ECGs were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who were treated with icatibant at least once during the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Changes in Clinical Laboratory Evaluations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-dose up to 97 days post-dose', 'description': 'Clinical laboratory evaluations included clinical chemistry (including liver function tests), hematology, urinalysis. The number of participants who reported clinically significant changes in clinical laboratory evaluations were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who were treated with icatibant at least once during the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Reported Presence of Anti-icatibant Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-dose up to 97 days post-dose', 'description': 'The number of participants who reported anti-icatibant antibodies were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who were treated with icatibant at least once during the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study drug administration up to 97 days post-dose', 'description': 'An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in a clinical study, whether or not considered investigational product related.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who were treated with icatibant at least once during the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'title': 'Any Reaction', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Any Severe Reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 h post-dose on Day 1 up to 9 days post-dose', 'description': 'The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occured after initial icatibant administration was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who were treated with icatibant at least once during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'title': 'E-2: HCP Administration: Any Reaction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCP Administration: Any Severe Reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: Caregiver Administration: Any Reaction', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'E-2: Caregiver Administration: Any Severe Reaction', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCP Administration: Any Reaction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCP Administration: Any Severe Reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: Caregiver Administration: Any Reaction', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'E-3: Caregiver Administration: Any Severe Reaction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 h post-dose up to 9 days post-dose', 'description': 'The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occurred after subsequent icatibant administration by study-site personnel (health care practitioner \\[HCP\\] administration) or by caregiver/self (caregiver administration) was reported. In the below table, E-2 refers to icatibant exposure 2 and E-3 refers to icatibant exposure 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who were treated with icatibant at least once during the study. Here the number of participants analyzed signifies participants who received subsequent icatibant exposures 2 and 3.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Changes in Reproductive Hormones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-dose up to 97 days post-dose', 'description': 'Reproductive hormone levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and progesterone in females, and FSH, LH, and testosterone in males were measured. The number of participants with clinically significant changes in reproductive hormones was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who were treated with icatibant at least once during the study.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration up to 8.5 hours post-dose', 'description': 'The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20 percent (%) improvement in the average post-treatment symptom score with no worsening of any single component score for the initial icatibant exposure. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of hereditary angioedema (HAE) using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). TOSR for participants who received initial icatibant administration was reported.', 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'title': 'Icatibant Exposure-2: HCP Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'comment': 'Percentage confidence interval (%CI) was not calculated due to less number of participants.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Icatibant Exposure-2: Caregiver Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.3'}]}]}, {'title': 'Icatibant Exposure-3: HCP Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'comment': '%CI was not calculated due to less number of participants.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Icatibant Exposure-3:Caregiver Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration up to 12 hours post-dose', 'description': 'The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20% improvement in the composite (or average) post-treatment symptom score with no worsening of any single component score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.', 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who received subsequent icatibant exposures 2 and 3.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration up to 52 hours post-dose', 'description': "The TOSR was defined as the earliest time at which the post-treatment score improved by at least one level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). TOSR for participants who received initial icatibant administration was reported.", 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'title': 'Icatibant Exposure-2: HCP Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'comment': '%CI was not calculated due to less number of participants.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Icatibant Exposure-2: Caregiver Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.2'}]}]}, {'title': 'Icatibant Exposure-3: HCP Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'comment': '%CI was not calculated due to less number of participants.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Icatibant Exposure-3:Caregiver Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration up to 28 hours post-dose', 'description': "The TOSR was defined as the earliest time at which the post-treatment score improved by at least one level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.", 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Symptom Relief (TOSR) for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'comment': '%CI was not calculated due to less number of participants.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration up to 8.5 hours post-dose', 'description': 'The TOSR was defined as the earliest time at which a 20% improvement was seen in the total post-treatment score. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. Face(F): 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); Legs(L): 0 (normal position/relaxed) - 2 (kicking/legs drawn up); Activity(A): 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); Cry(C): 0 (No cry \\[awake/asleep\\]) - 2 (crying steadily/screams/sobs or frequent complaints); Consolability(C): 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.', 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants of 4 years and younger with FLACC data.'}, {'type': 'SECONDARY', 'title': 'Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration up to 8.5 hours post-dose', 'description': 'Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received initial icatibant administration was reported.', 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'title': 'Icatibant Exposure-2: HCP Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Icatibant Exposure-2: Caregiver Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Icatibant Exposure-3: HCP Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Icatibant Exposure-3: Caregiver Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'comment': 'The data was not calculated due to analysis method limitation.', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration up to 12 hours post-dose', 'description': 'Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.', 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '5.3'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '6.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration up to 52 hours post-dose', 'description': "Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). Time to minimum symptom for participants who received initial icatibant administration was reported.", 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.'}, {'type': 'SECONDARY', 'title': 'Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'title': 'Icatibant Exposure-2: HCP Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'comment': 'The %CI was not calculated due to less number of participants.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Icatibant Exposure-2: Caregiver Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': 'Icatibant Exposure-3: HCP Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.8', 'comment': 'The %CI was not calculated due to less number of participants.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Icatibant Exposure-3:Caregiver Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '24.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration up to 28 hours post-dose', 'description': "Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.", 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.'}, {'type': 'SECONDARY', 'title': 'Time to Minimum Symptom for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'comment': 'The %CI was not calculated due to less number of participants.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration up to 8.5 hours post-dose', 'description': 'Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which the total post-treatment score improved to zero. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. (F) Face: 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); (L) Legs: 0 (normal position/relaxed) - 2 (kicking/legs drawn up); (A) Activity: 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); (C) Cry: 0 (No cry \\[awake/asleep\\]) - 2 (crying steadily/screams/sobs or frequent complaints); (C) Consolability: 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.', 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from efficacy population with FLACC data.'}, {'type': 'SECONDARY', 'title': 'Time to Use of Rescue Medication for the Treatment of Symptoms of the Hereditary Angioedema (HAE) Attack Following Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'This analysis was planned to be performed if there were at least 5 participants for a given attack who used rescue medication prior to attaining symptom relief.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'This analysis was planned to be performed if there were at least 5 participants for a given attack who used rescue medication prior to attaining symptom relief.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of study drug administration up to 52 hours post-dose', 'description': 'Rescue medication was any medication used after the administration of icatibant which, in the opinion of the investigator, was immediately necessary to alleviate acute symptoms which are judged by the investigator as resultant from the current HAE attack. Time to first use of rescue medication prior to the onset of symptom relief was calculated from the time of study drug administration to the first use of rescue medication prior to the onset of symptom relief. This analysis was not performed since as per protocol, "This analysis will only be performed if there are at least 5 participants for a given attack who used rescue medication prior to attaining symptom relief".', 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'OG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'title': 'Abdominal Tenderness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin Pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin Irritation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin Swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 2 hours post-dose to 4 hours post-dose', 'description': 'The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5- point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours postdose were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who evaluable for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'classes': [{'title': 'E-2: HCPA: Abdominal Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2:CA: Abdominal Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2:HCPA: Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Skin Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Skin Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Skin Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Skin Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Skin Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Skin Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Voice Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Voice Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Breathing Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Breathing Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Stridor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: CA: Stridor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2: HCPA: Asphyxia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-2:CA: Asphyxia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Abdominal Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Abdominal Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Skin Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Skin Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Skin Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Skin Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Skin Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Skin Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Voice Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Voice Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Breathing Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Breathing Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Stridor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Stridor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: HCPA: Asphyxia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'E-3: CA: Asphyxia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 2 hours post-dose to 4 hours post-dose', 'description': 'The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5- point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours post-dose were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. The number of participants analyzed signifies participants evaluable for this endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prepubertal', 'description': 'Participants received a single subcutaneous (SC) injection of 0.4 milligram per kilogram (mg/kg) icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'FG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}], 'periods': [{'title': 'Initial Icatibant Exposure', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lack of adherence and poor compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Icatibant Exposure 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Icatibant Exposure 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 27 study centers in the United States, Germany, Israel, Spain, Argentina, Australia, Austria, Canada, Colombia, Hungary, and Italy between 27 January 2012 (first participant first visit) and 12 March 2018 (last participant last visit).', 'preAssignmentDetails': 'A total of 32 participants were enrolled and received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prepubertal', 'description': 'Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.'}, {'id': 'BG001', 'title': 'Pubertal/Postpubertal', 'description': 'Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '2.97', 'groupId': 'BG000'}, {'value': '14.3', 'spread': '1.66', 'groupId': 'BG001'}, {'value': '12.3', 'spread': '3.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population consisted of participants who were treated with icatibant at least once during the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-06-14', 'size': 1461362, 'label': 'Study Protocol: Protocol Original', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-14T06:17', 'hasProtocol': True}, {'date': '2011-08-05', 'size': 2313237, 'label': 'Study Protocol: Protocol Amendment 1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-14T06:18', 'hasProtocol': True}, {'date': '2012-03-06', 'size': 5124321, 'label': 'Study Protocol: Protocol Amendment 2', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-14T06:20', 'hasProtocol': True}, {'date': '2013-06-19', 'size': 5311071, 'label': 'Study Protocol: Protocol Amendment 3', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-14T06:21', 'hasProtocol': True}, {'date': '2016-03-18', 'size': 1739913, 'label': 'Study Protocol: Protocol Amendment 4', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-14T06:22', 'hasProtocol': True}, {'date': '2018-04-24', 'size': 4348859, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-14T06:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2011-06-28', 'resultsFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2011-06-30', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-21', 'studyFirstPostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Time to peak concentration (Tmax) of a single SC dose of icatibant was reported.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Maximum plasma concentration (Cmax) of a single SC dose of icatibant was reported.'}, {'measure': 'Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Total plasma clearance (CL/F) of a single SC dose of icatibant was reported.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4) of a Single Subcutaneous (SC) Dose of Icatibant', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, and 4 hours post-dose on Day 1', 'description': 'Area under the plasma concentration-time curve from time zero to 4 hours post-dose (AUC0-4) of a single SC dose of icatibant was reported.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours Post-dose (AUC0-t) of a Single Subcutaneous (SC) Dose of Icatibant', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Area under the plasma concentration-time curve from time zero to 6 hours post-dose (AUC0-t) of a single SC dose of icatibant was reported.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of a Single Subcutaneous (SC) Dose of Icatibant', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of a single SC dose of icatibant was reported.'}, {'measure': 'Volume of Distribution (Vz/F) of a Single Subcutaneous (SC) Dose of Icatibant', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Volume of distribution (Vz/F) of a single SC dose of icatibant was reported.'}, {'measure': 'Elimination Half-life (t1/2) of a Single Subcutaneous (SC) Dose of Icatibant', 'timeFrame': 'Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1', 'description': 'Elimination half-life (t1/2) of a single SC dose of icatibant was reported.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs', 'timeFrame': 'Pre-dose up to 97 days post-dose', 'description': 'Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants who reported clinically significant changes in vital signs were reported.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)', 'timeFrame': '6 - 8 hours post-dose on Day 1', 'description': 'A standard 12-lead ECG was performed after 10 minutes at rest when the participant was seated or supine following treatment. The number of participants who reported clinically significant changes in ECGs were reported.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Clinical Laboratory Evaluations', 'timeFrame': 'Pre-dose up to 97 days post-dose', 'description': 'Clinical laboratory evaluations included clinical chemistry (including liver function tests), hematology, urinalysis. The number of participants who reported clinically significant changes in clinical laboratory evaluations were reported.'}, {'measure': 'Number of Participants Who Reported Presence of Anti-icatibant Antibodies', 'timeFrame': 'Pre-dose up to 97 days post-dose', 'description': 'The number of participants who reported anti-icatibant antibodies were reported.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From the start of study drug administration up to 97 days post-dose', 'description': 'An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in a clinical study, whether or not considered investigational product related.'}, {'measure': 'Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 1', 'timeFrame': '1 h post-dose on Day 1 up to 9 days post-dose', 'description': 'The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occured after initial icatibant administration was reported.'}, {'measure': 'Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 2 and 3', 'timeFrame': '1 h post-dose up to 9 days post-dose', 'description': 'The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occurred after subsequent icatibant administration by study-site personnel (health care practitioner \\[HCP\\] administration) or by caregiver/self (caregiver administration) was reported. In the below table, E-2 refers to icatibant exposure 2 and E-3 refers to icatibant exposure 3.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Reproductive Hormones', 'timeFrame': 'Pre-dose up to 97 days post-dose', 'description': 'Reproductive hormone levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and progesterone in females, and FSH, LH, and testosterone in males were measured. The number of participants with clinically significant changes in reproductive hormones was reported.'}], 'secondaryOutcomes': [{'measure': 'Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1', 'timeFrame': 'From start of study drug administration up to 8.5 hours post-dose', 'description': 'The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20 percent (%) improvement in the average post-treatment symptom score with no worsening of any single component score for the initial icatibant exposure. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of hereditary angioedema (HAE) using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). TOSR for participants who received initial icatibant administration was reported.'}, {'measure': 'Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3', 'timeFrame': 'From start of study drug administration up to 12 hours post-dose', 'description': 'The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20% improvement in the composite (or average) post-treatment symptom score with no worsening of any single component score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.'}, {'measure': 'Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1', 'timeFrame': 'From start of study drug administration up to 52 hours post-dose', 'description': "The TOSR was defined as the earliest time at which the post-treatment score improved by at least one level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). TOSR for participants who received initial icatibant administration was reported."}, {'measure': 'Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3', 'timeFrame': 'From start of study drug administration up to 28 hours post-dose', 'description': "The TOSR was defined as the earliest time at which the post-treatment score improved by at least one level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported."}, {'measure': 'Time to Onset of Symptom Relief (TOSR) for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores', 'timeFrame': 'From start of study drug administration up to 8.5 hours post-dose', 'description': 'The TOSR was defined as the earliest time at which a 20% improvement was seen in the total post-treatment score. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. Face(F): 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); Legs(L): 0 (normal position/relaxed) - 2 (kicking/legs drawn up); Activity(A): 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); Cry(C): 0 (No cry \\[awake/asleep\\]) - 2 (crying steadily/screams/sobs or frequent complaints); Consolability(C): 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.'}, {'measure': 'Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1', 'timeFrame': 'From start of study drug administration up to 8.5 hours post-dose', 'description': 'Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received initial icatibant administration was reported.'}, {'measure': 'Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3', 'timeFrame': 'From start of study drug administration up to 12 hours post-dose', 'description': 'Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.'}, {'measure': 'Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1', 'timeFrame': 'From start of study drug administration up to 52 hours post-dose', 'description': "Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). Time to minimum symptom for participants who received initial icatibant administration was reported."}, {'measure': 'Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3', 'timeFrame': 'From start of study drug administration up to 28 hours post-dose', 'description': "Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported."}, {'measure': 'Time to Minimum Symptom for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores', 'timeFrame': 'From start of study drug administration up to 8.5 hours post-dose', 'description': 'Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which the total post-treatment score improved to zero. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. (F) Face: 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); (L) Legs: 0 (normal position/relaxed) - 2 (kicking/legs drawn up); (A) Activity: 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); (C) Cry: 0 (No cry \\[awake/asleep\\]) - 2 (crying steadily/screams/sobs or frequent complaints); (C) Consolability: 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.'}, {'measure': 'Time to Use of Rescue Medication for the Treatment of Symptoms of the Hereditary Angioedema (HAE) Attack Following Study Drug Administration', 'timeFrame': 'From the start of study drug administration up to 52 hours post-dose', 'description': 'Rescue medication was any medication used after the administration of icatibant which, in the opinion of the investigator, was immediately necessary to alleviate acute symptoms which are judged by the investigator as resultant from the current HAE attack. Time to first use of rescue medication prior to the onset of symptom relief was calculated from the time of study drug administration to the first use of rescue medication prior to the onset of symptom relief. This analysis was not performed since as per protocol, "This analysis will only be performed if there are at least 5 participants for a given attack who used rescue medication prior to attaining symptom relief".'}, {'measure': 'Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 1', 'timeFrame': 'From 2 hours post-dose to 4 hours post-dose', 'description': 'The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5- point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours postdose were reported.'}, {'measure': 'Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 2 and 3', 'timeFrame': 'From 2 hours post-dose to 4 hours post-dose', 'description': 'The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5- point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours post-dose were reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Efficacy', 'Hereditary angioedema', 'HAE', 'Pediatric', 'Children', 'Pharmacokinetics', 'Safety', 'Firazyr', 'icatibant'], 'conditions': ['Hereditary Angioedema (HAE)']}, 'referencesModule': {'references': [{'pmid': '28601641', 'type': 'DERIVED', 'citation': 'Farkas H, Reshef A, Aberer W, Caballero T, McCarthy L, Hao J, Nothaft W, Schranz J, Bernstein JA, Li HH. Treatment Effect and Safety of Icatibant in Pediatric Patients with Hereditary Angioedema. J Allergy Clin Immunol Pract. 2017 Nov-Dec;5(6):1671-1678.e2. doi: 10.1016/j.jaip.2017.04.010. Epub 2017 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.', 'detailedDescription': 'Study HGT-FIR-086 will enroll 30 subjects from 2 to less than 18 years of age, divided into 2 groups: prepubertal and pubertal/postpubertal. At least 10 prepubertal children and at least 20 adolescents (including 10 treated during a HAE attack) must be enrolled in the study.\n\nAfter a qualifying screening period, the PK, safety/tolerability, and efficacy of treatment with SC icatibant will be evaluated in at least 20 subjects (10 prepubertal and 10 pubertal/postpubertal subjects) who present with cutaneous, abdominal, or laryngeal symptoms of an acute attack of HAE. The PK and safety/tolerability of SC icatibant will be evaluated in at least 10 additional pubertal/postpubertal subjects who meet screening criteria and receive treatment with SC icatibant in the absence of a current acute HAE attack.\n\nThe planned duration of active participation for subjects who present with an initial attack of acute HAE will consist of treatment with a single subcutaneous injection of icatibant on Day 1 through follow up at day 90.\n\nAfter having received initial treatment with icatibant, either during or in the absence of an attack, at least 10 pubertal/postpubertal subjects who subsequently experience an acute HAE attack may continue to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant-treated attacks.\n\nThe period of active participation in the study for prepubertal subjects will be approximately 90 days, while that for pubertal/postpubertal subjects could be a maximum of approximately 270 or 360 days (3 separate active periods of approximately 90 days for those treated with icatibant during an attack; 4 separate active periods for those treated without an attack), with each active period separated by periods of inactive participation of variable duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Two through \\<18 years of age at the time of first HAE attack.\n\n * Prepubertal and pubertal/postpubertal subjects experiencing and acute cutaneous, abdominal, or laryngeal HAE attack treated with icatibant as part of this study.\n * Pubertal/postpubertal subjects with HAE who are treated with icatibant, but not during an attack.\n2. Documented diagnosis of HAE Type I or II.\n3. Informed consent (and subject assent as appropriate) signed by the subject's parent(s)or legal guardian(s).\n\nExclusion Criteria:\n\n1. Diagnosis of angioedema other than HAE.\n2. Participation in another clinical trial that involves the use of any investigational product (drug or device)within 30 days prior to study enrollment or at any time during the study.\n3. Any known factor/disease that might interfere with the treatment compliance, study conduct,or result interpretation.\n4. Congenital or acquired cardiac anomalies that interfere significantly with cardiac function.\n5. Treatment with ACE inhibitors within 7 days prior to treatment.\n6. Use of hormonal contraception within the 90 days prior to treatment.\n7. Androgen use (eg, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within the 90 days prior to treatment.\n8. Pregnancy or breastfeeding.\n9. A physical condition that interferes with pubertal status determination."}, 'identificationModule': {'nctId': 'NCT01386658', 'briefTitle': 'A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Administration of Icatibant in Children and Adolescents With Hereditary Angioedema', 'orgStudyIdInfo': {'id': 'HGT-FIR-086'}, 'secondaryIdInfos': [{'id': '2011-003825-81', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Icatibant', 'description': 'Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg', 'interventionNames': ['Drug: icatibant']}], 'interventions': [{'name': 'icatibant', 'type': 'DRUG', 'otherNames': ['Firazyr'], 'description': 'Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg', 'armGroupLabels': ['Icatibant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Breathe America', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Institute for Asthma and Allergy, PC', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45231', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bernstein Clinical Research Center, LLC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43617', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Institute of Clinical Research', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73131', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Institute of Allergy and Asthma Clinical Research, LLC', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97035', 'city': 'Lake Oswego', 'state': 'Oregon', 'country': 'United States', 'facility': 'Allergy Asthma Dermatology Research Center', 'geoPoint': {'lat': 45.42067, 'lon': -122.67065}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'AARA Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '2560', 'city': 'Campbelltown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Campbelltown Hospital', 'geoPoint': {'lat': -34.06667, 'lon': 150.81667}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinische Universität Graz Hautklinik', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'L8S 4K1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Bogota', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Hospital Infantil Universitario de San Jose'}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum der Johann Wolfgang Goethe University', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Johannes-Gutenberg University Clinical Research Center', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '64546', 'city': 'Walldorf', 'country': 'Germany', 'facility': 'HZRM Hämophilie Zentrum Rhein Main GmbH', 'geoPoint': {'lat': 49.30637, 'lon': 8.64236}}, {'zip': 'H-1131', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Heim Pal Childrens Hospital', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Bnai Zion Medical Center, Allergy and Immunology Institute', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Sourasky Medical Center, Pulmonology and Allergy Unit', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center Allergy and Immunology Angioedema Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'University of Naples Federico II, Dipartimento di Medicina Interna', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Unidad de Alergia, Edif. Consultas Externas, Planta Baja HOSPITAL UNIVERSITARIO LA PAZ', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'University Hospital, Pediatric Pulmonology and Allergy Unit', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}