Viewing Study NCT02303093

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Ignite Creation Date: 2025-12-25 @ 1:18 AM
Ignite Modification Date: 2026-02-20 @ 8:32 PM
Study NCT ID: NCT02303093
Status: COMPLETED
Last Update Posted: 2021-06-29
First Post: 2014-11-20
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Non-Interventional Study on the Tolerability and Efficacy of IVIG
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000617884', 'term': 'Panzyga'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bernhard.rohrbacher@octapharma.com', 'phone': '+431610324182', 'title': 'Dr. Bernhard Rohrbacher', 'organization': 'Octapharma Pharmazeutika Produktionsgesm.b.H.,'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Approximately 12 months, observational study', 'eventGroups': [{'id': 'EG000', 'title': 'Octagam 5%', 'description': 'Octagam 5%', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 13, 'seriousNumAtRisk': 139, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Octagam 10%', 'description': 'Octagam 10%', 'otherNumAtRisk': 183, 'deathsNumAtRisk': 183, 'otherNumAffected': 37, 'seriousNumAtRisk': 183, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Octagam 5% and Octagam 10%, While Under Octagam 5%', 'description': 'Octagam 5% and Octagam 10%, while under Octagam 5%', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Octagam 5% and Octagam 10%, While Under Octagam 10%', 'description': 'Octagam 5% and Octagam 10%, while under Octagam 10%', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Octagam 10% and Panzyga, While Under Octagam 10%', 'description': 'Octagam 10% and Panzyga, while under Octagam 10%', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Octagam 10% and Panzyga, While Under Panzyga', 'description': 'Octagam 10% and Panzyga, while under Panzyga', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FEELING COLD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FEELING OF BODY TEMPERATURE CHANGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DISTURBANCE IN ATTENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PARAESTHESIA ORAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPERHIDROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COLD SWEAT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH PRURITIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH ERYTHEMATOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FLUSHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MUSCULOSKELETAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DYSPHONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLOOD GLUCOSE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SLEEP DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CYANOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 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0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 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0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 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'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Unfavourable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Missing', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Duration of infections', 'categories': [{'title': 'Beneficial', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Unchanged', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Unfavourable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 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Not all patients attended respective visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients', 'description': 'All patients'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'All patients'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '93'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '160', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '184', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '138', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '199', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-27', 'size': 247281, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-03T14:24', 'hasProtocol': True}, {'date': '2020-04-14', 'size': 716895, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-03T14:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-05', 'studyFirstSubmitDate': '2014-11-20', 'resultsFirstSubmitDate': '2021-06-05', 'studyFirstSubmitQcDate': '2014-11-24', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-05', 'studyFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Drug Reactions', 'timeFrame': 'up to one year', 'description': 'Number of patients with adverse drug reactions'}], 'secondaryOutcomes': [{'measure': 'Infection Occurrence', 'timeFrame': 'Up to one year', 'description': 'Pool of PID/SID Patients: Influence of IVIG/SCIG Treatment. Frequency, intensity, and duration of infectious episodes assessed. At the last available assessment, the influence of study IVIG on the frequency, intensity, and duration of the infections.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG']}, 'descriptionModule': {'briefSummary': 'Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%', 'detailedDescription': 'A Non-Interventional Study on the Tolerability and Efficacy of Octagam 5% or 10% or panzyga. Patients with any indication (replacement and immonomodulation) as prescribed by the treating physician. Marketed Octagam 5% or 10% or panzyga will be used according to the investigator prescription; intravenous (iv) administration.The primary objective is to detect and evaluate adverse drug reactions (ADRs) occurring during or after the administration of Octagam or panzyga in any indication, age group or treatment regimen, where a causal relationship to the administration of Octagam or panzyga is suspected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe 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