Ignite Creation Date:
2025-12-25 @ 4:22 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT00814320
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2008-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Gammagard Liquid and rHuPH20 in PID
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': "Baxter's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 12 months after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥30 days prior to submission or communication. Baxter may request an additional delay of ≤60 days eg, for intellectual property protection", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'IV Administration of IGIV, 10%', 'description': 'Consists of Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of IV infusions of immune globulin intravenous (IGIV), 10%.', 'otherNumAtRisk': 87, 'otherNumAffected': 67, 'seriousNumAtRisk': 87, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)', 'description': 'Consists of participants treated SC with IGIV, 10% at 108% of IV dose during administration of IGIV, 10%. This arm INCLUDES participants during ramp-up. Ramp-up: Participants were treated with SC infusions of IGIV, 10% with recombinant human hyaluronidase (rHuPH20). Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. During SC administration of IGIV, 10% with rHuPh20, aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.', 'otherNumAtRisk': 83, 'otherNumAffected': 81, 'seriousNumAtRisk': 83, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'LYMPHADENOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 28, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 25, 'numAffected': 14}], 'organSystem': 'General disorders'}, {'term': 'INFUSION SITE DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 33, 'numAffected': 10}], 'organSystem': 'General disorders'}, {'term': 'INFUSION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 47, 'numAffected': 14}], 'organSystem': 'General disorders'}, {'term': 'INFUSION SITE OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 16, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'INFUSION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 129, 'numAffected': 37}], 'organSystem': 'General disorders'}, {'term': 'INFUSION SITE PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 21, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'INFUSION SITE SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 13, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'LOCAL SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'General disorders'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 26, 'numAffected': 13}], 'organSystem': 'General disorders'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Infections and infestations'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations'}, {'term': 'CHRONIC SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Infections and infestations'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Infections and infestations'}, {'term': 'POST PROCEDURAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 59, 'numAffected': 35}], 'organSystem': 'Infections and infestations'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 49, 'numAffected': 32}], 'organSystem': 'Infections and infestations'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'VIRAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Infections and infestations'}, {'term': 'VIRAL UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'PROCEDURAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 21, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Nervous system disorders'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 53, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 63, 'numAffected': 27}], 'organSystem': 'Nervous system disorders'}, {'term': 'MIGRAINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 14, 'numAffected': 6}], 'organSystem': 'Nervous system disorders'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 28, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'NASAL CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'RHINITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Adrenocortical Insufficiency Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders'}, {'term': 'Peptic Ulcer Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Back Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Grand Mal Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Petit Mal Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Status Epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cervical Dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Tonsillar Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Leukoplakia Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Localised Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Validated Acute Serious Bacterial Infection (VASBI) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Data Set (FADS)', 'description': 'All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.025', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Poisson', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '99', 'paramValue': '0.025', 'ciUpperLimit': '0.046', 'pValueComment': 'Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.', 'groupDescription': 'For SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only', 'statisticalMethod': 'Poisson', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen. VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only. The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant.', 'unitOfMeasure': 'Estimated infections/year', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '% Ratio IgG AUC/Week of SC/ IV', 'description': 'Percentage Ratio of IgG AUC (/Week) after SC administration with rHuPH20/ IgG AUC (/Week) after IV administration of IGIV, 10%'}], 'classes': [{'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '91.4', 'upperLimit': '95.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion', 'description': 'Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of ratio of Area Under the Concentration Curve (AUC)/Week after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.', 'unitOfMeasure': 'Percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with AUC measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '%Ratio IgG Trough Level of SC/IV', 'description': 'Percentage Ratio IgGTrough Level after SC administration with rHuPH20/IgG versus after IV administration of IGIV, 10% for participants aged 2 to \\< 12 years'}], 'classes': [{'categories': [{'measurements': [{'value': '103.8', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '115.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit', 'description': 'Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of trough levels after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 2 to \\< 12 years exposed to either or both study drugs with available IgG trough level measurements'}, {'type': 'SECONDARY', 'title': 'Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ratio IgG AUC of SC With and Without rHuPH20', 'description': 'Percentage Ratio of IgG AUC (dose per kg) with and without rHuPH20 for SC administration of IGIV, 10%'}], 'classes': [{'title': 'Participants in Stratum A (N=19)', 'categories': [{'measurements': [{'value': '118.7', 'groupId': 'OG000', 'lowerLimit': '113.6', 'upperLimit': '124.1'}]}]}, {'title': 'Participants in Stratum B (N=54)', 'categories': [{'measurements': [{'value': '133.6', 'groupId': 'OG000', 'lowerLimit': '118.3', 'upperLimit': '150.8'}]}]}, {'title': 'Total Participants (N=73)', 'categories': [{'measurements': [{'value': '120.4', 'groupId': 'OG000', 'lowerLimit': '115.5', 'upperLimit': '125.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf.', 'description': 'Bioavailability of immunoglobulin (IgG) after subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10%, with and without recombinant human hyaluronidase (rHuPH20) (from current study 160603 and study 160601, respectively), as measured by ratio of AUC of IgG per dose/kg with versus without rHuPH20. Expressed as a percentage. This was analysed for participants in Stratum A , participants in Stratum B and for all participants who received IGIV, 10% via SC administration (Stratum A plus Stratum B): Stratum A: Participants who provided data both on SC with AND without rHuPH20 ie, participants who participated in both studies 160601 and 160603; Stratum B: Participants who provided data on SC with OR without rHuPH20, but not on both (participants who participated in study 160601 OR 160603, but not in both studies).', 'unitOfMeasure': 'Percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Data Set aged ≥ 12 years from the current study (160603) and prior Baxter study 160601 who received IGIV, 10% via SC administration'}, {'type': 'SECONDARY', 'title': 'Annual Rate of All Infections Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up'}], 'classes': [{'categories': [{'measurements': [{'value': '4.51', 'groupId': 'OG000', 'lowerLimit': '3.50', 'upperLimit': '5.69'}, {'value': '2.97', 'groupId': 'OG001', 'lowerLimit': '2.51', 'upperLimit': '3.47'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Annual rate of all infections per participant after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the annual rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary endpoint.', 'unitOfMeasure': 'Estimated infections/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years'}, {'id': 'OG001', 'title': 'Participants ≥12 Years'}], 'classes': [{'title': 'end of IV part', 'categories': [{'measurements': [{'value': '9.63', 'groupId': 'OG000', 'lowerLimit': '8.29', 'upperLimit': '13.60'}, {'value': '10.40', 'groupId': 'OG001', 'lowerLimit': '9.63', 'upperLimit': '11.4'}]}]}, {'title': 'end of SC with rHuPH20 part', 'categories': [{'measurements': [{'value': '9.95', 'groupId': 'OG000', 'lowerLimit': '7.87', 'upperLimit': '15.00'}, {'value': '10.70', 'groupId': 'OG001', 'lowerLimit': '9.46', 'upperLimit': '11.80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit.', 'description': 'Trough levels of immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up', 'unitOfMeasure': 'g/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years'}, {'id': 'OG001', 'title': 'Participants ≥ 12 Years'}], 'classes': [{'title': 'IgG 1 end of IV treatment (N=11,69)', 'categories': [{'measurements': [{'value': '490.0', 'groupId': 'OG000', 'lowerLimit': '414.0', 'upperLimit': '752.0'}, {'value': '574.0', 'groupId': 'OG001', 'lowerLimit': '514.0', 'upperLimit': '638.0'}]}]}, {'title': 'IgG 1 end of SC/rHuPH20 treatment (N=11,70)', 'categories': [{'measurements': [{'value': '455.0', 'groupId': 'OG000', 'lowerLimit': '411.0', 'upperLimit': '805.0'}, {'value': '548.0', 'groupId': 'OG001', 'lowerLimit': '513.0', 'upperLimit': '602.0'}]}]}, {'title': 'IgG 2 end of IV treatment (N=11,69)', 'categories': [{'measurements': [{'value': '327.0', 'groupId': 'OG000', 'lowerLimit': '250.0', 'upperLimit': '538.0'}, {'value': '360.0', 'groupId': 'OG001', 'lowerLimit': '334.0', 'upperLimit': '390.0'}]}]}, {'title': 'IgG 2 end of SC/rHuPH20 treatment (N=11,70)', 'categories': [{'measurements': [{'value': '315.0', 'groupId': 'OG000', 'lowerLimit': '280.0', 'upperLimit': '550.0'}, {'value': '339.0', 'groupId': 'OG001', 'lowerLimit': '318.0', 'upperLimit': '374.0'}]}]}, {'title': 'IgG 3 end of IV treatment (N=11,69)', 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '66.0'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '27.0', 'upperLimit': '37.0'}]}]}, {'title': 'IgG 3 end of SC/rHuPH20 treatment (N=11,70)', 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '26.0', 'upperLimit': '83.0'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '32.0', 'upperLimit': '43.0'}]}]}, {'title': 'IgG 4 end of IV treatment (N=11,69)', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '55.0'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '20.0'}]}]}, {'title': 'IgG 4 end of SC/rHuPH20 treatment (N=11,70)', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '57.0'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '19.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit', 'description': 'Trough levels of immunoglobulin (IgG) subclasses after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up by IgG subclasses 1 to 4 at end of IV treatment and end of SC treatment with rHuPH20 IgG subclass 1 (IgG 1) IgG subclass 2 (IgG 2) IgG subclass 3 (IgG 3) IgG subclass 4 (IgG 4)', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who have been exposed to either or both study drugs with available IgG subclass trough level measurements'}, {'type': 'SECONDARY', 'title': 'Antibody Levels to Tetanus (Clostridium Tetani Toxoid)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years'}, {'id': 'OG001', 'title': 'Participants ≥ 12 Years'}], 'classes': [{'title': 'End of IV treatment (N=7,25)', 'categories': [{'measurements': [{'value': '2.230', 'groupId': 'OG000', 'lowerLimit': '0.0640', 'upperLimit': '4.230'}, {'value': '2.320', 'groupId': 'OG001', 'lowerLimit': '1.810', 'upperLimit': '2.710'}]}]}, {'title': 'End of SC/rHuPH20 treatment (N=10,70)', 'categories': [{'measurements': [{'value': '2.580', 'groupId': 'OG000', 'lowerLimit': '0.990', 'upperLimit': '3.810'}, {'value': '2.525', 'groupId': 'OG001', 'lowerLimit': '2.270', 'upperLimit': '2.850'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit', 'description': 'Antibody levels to Tetanus (Clostridium tetani toxoid) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Full Analysis Data Set with available specific antibody test results'}, {'type': 'SECONDARY', 'title': 'Antibody Levels to Haemophilus Influenzae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years'}, {'id': 'OG001', 'title': 'Participants ≥ 12 Years'}], 'classes': [{'title': 'Influenza antibody end of IV treatment (N=7,24)', 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000', 'lowerLimit': '1.59', 'upperLimit': '13.52'}, {'value': '2.36', 'groupId': 'OG001', 'lowerLimit': '2.05', 'upperLimit': '3.05'}]}]}, {'title': 'Influenza antibody end of SC treatment (N=10,70)', 'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.94'}, {'value': '2.58', 'groupId': 'OG001', 'lowerLimit': '2.30', 'upperLimit': '2.95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit', 'description': 'Antibody levels to Haemophilus influenzae after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Full Analysis Data Set with available specific antibody test results'}, {'type': 'SECONDARY', 'title': 'Antibody Levels to Measles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years'}, {'id': 'OG001', 'title': 'Participants ≥ 12 Years'}], 'classes': [{'title': 'Measles antibody end of IV treatment (N=0,1)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No entry in this category/arm', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '64.0', 'comment': 'One entry in this category/arm', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Measles antibody end of SC treatment (N=10,70)', 'categories': [{'measurements': [{'value': '768.0', 'groupId': 'OG000', 'lowerLimit': '256.0', 'upperLimit': '2048.0'}, {'value': '1024.0', 'groupId': 'OG001', 'lowerLimit': '512.0', 'upperLimit': '1024.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit', 'description': 'Antibody levels to measles after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Data Set with available specific antibody test results'}, {'type': 'SECONDARY', 'title': 'Antibody Levels to Hepatitis B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years'}, {'id': 'OG001', 'title': 'Participants ≥ 12 Years'}], 'classes': [{'title': 'Hepatitis B antibody end IV treatment (N=6,25)', 'categories': [{'measurements': [{'value': '212.9', 'groupId': 'OG000', 'lowerLimit': '59.5', 'upperLimit': '291.5'}, {'value': '222.8', 'groupId': 'OG001', 'lowerLimit': '190.3', 'upperLimit': '289.4'}]}]}, {'title': 'Hepatitis B antibody end of SC treatment (N=10,70)', 'categories': [{'measurements': [{'value': '242.2', 'groupId': 'OG000', 'lowerLimit': '125.5', 'upperLimit': '871.9'}, {'value': '249.2', 'groupId': 'OG001', 'lowerLimit': '225.0', 'upperLimit': '289.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit', 'description': 'Antibody levels to hepatitis B after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Data Set with available specific antibody test results'}, {'type': 'SECONDARY', 'title': 'IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '10.9'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '11.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion', 'description': 'Minimal immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and Older', 'unitOfMeasure': 'g/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000', 'lowerLimit': '89.1', 'upperLimit': '102.1'}, {'value': '90.5', 'groupId': 'OG001', 'lowerLimit': '83.8', 'upperLimit': '98.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Immunoglobulin (IgG) Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval).', 'unitOfMeasure': 'g*days/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'IgG Clearance (CL) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '1.4'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Immunoglobulin (IgG) Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance and apparent clearance are determined by weight adjusted dose divided by total AUC.', 'unitOfMeasure': 'mL/kg/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '23.9'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '17.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Maximum immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older', 'unitOfMeasure': 'g/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '32.4', 'upperLimit': '40.4'}, {'value': '45.3', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '60.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Terminal half life (T1/2) for immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50% during the terminal phase', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.1'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '5.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Time to Maximum Immunoglobulin (IgG) Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '2.7'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '2.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Minimal tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '32.2'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '19.9', 'upperLimit': '25.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Tetanus (clostridium tetani toxoid) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval).', 'unitOfMeasure': 'IU*days/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '5.1'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Tetanus (clostridium tetani toxoid) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC.', 'unitOfMeasure': 'nL/IU/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '28.1'}, {'value': '30.4', 'groupId': 'OG001', 'lowerLimit': '25.7', 'upperLimit': '37.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Terminal half life (T1/2) for tetanus (clostridium tetani toxoid) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of tetanus antibody in the body to be reduced by 50% during the terminal phase', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '8.1'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Maximum tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.2'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Time to Maximum tetanus (clostridium tetani toxoid) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '2.6'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Minimal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': '26.6'}, {'value': '22.5', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '24.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Influenza (haemophilus influenzae) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval).', 'unitOfMeasure': 'μg*days/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '6.5'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '7.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Influenza (haemophilus influenzae) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC.', 'unitOfMeasure': 'L/kg/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '6.8'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Maximal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '45.3'}, {'value': '35.0', 'groupId': 'OG001', 'lowerLimit': '32.3', 'upperLimit': '41.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Terminal half life (T1/2) for influenza (haemophilus influenzae) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of influenza antibody in the body to be reduced by 50% during the terminal phase.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.2'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Time to Maximum influenza (haemophilus influenzae) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\\* SC- Days 1, 3, 5, 9, 14, 21, 28\\* \\*Measurements at Day 28 for the 4-week treatment interval only'}, {'type': 'SECONDARY', 'title': 'Rate of Days Off School or Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.34'}, {'value': '0.28', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '0.37'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Monthly, for up to 17 months', 'description': 'Monthly rate of days off school or work after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month were defined as average length of the month in the Gregorian calendar, namely (365\\*400+100-3)/(400\\*12)= 30.436875 days.', 'unitOfMeasure': 'Days off per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Rate of Days on Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'groupId': 'OG000', 'lowerLimit': '2.19', 'upperLimit': '4.35'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '2.16'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Monthly, for up to 17 months', 'description': 'Monthly rate of days on antibiotics after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month was defined as average length of the month in the Gregorian calendar, namely (365\\*400+100-3)/(400\\*12)= 30.436875 days.', 'unitOfMeasure': 'Days on antibiotics per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Rate of Acute Physician Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.45'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '0.32', 'upperLimit': '0.49'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Monthly, for up to 17 months', 'description': 'Monthly rate of acute physician visits after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365\\*400+100-3)/(400\\*12)= 30.436875 days.', 'unitOfMeasure': 'Visits per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Rate of Days in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.10'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.03'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Monthly, for up to 17 months', 'description': 'Monthly rate of days in hospital after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365\\*400+100-3)/(400\\*12)= 30.436875 days.', 'unitOfMeasure': 'Days per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': '% participants with reduced infusion rate only', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '9.9', 'groupId': 'OG001'}]}]}, {'title': '% participants with interrupted infusion rate only', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}]}]}, {'title': '% participants with infusion stopped only', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': '% participants with no changes to infusion rate', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000'}, {'value': '84.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Percentage of participants for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs). An infusion was deemed as tolerated if there are no serious Adverse Drug Reactions (ADR), no non-serious moderate or severe local ADRs that prevent completion of the infusion and no non-serious moderate or severe systemic ADRs during infusion or within 60 minutes of completion of the infusion.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': '% infusions with infusion rate reduced only', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': '% infusions with interrupted infusion rate only', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}, {'title': '% infusions with infusion stopped only', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}, {'title': '% infusions with no changes to infusion rate', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000'}, {'value': '97.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Percentage of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs). IV administration of IGIV, 10%: 365 infusions; SC administration of IGIV, 10% with rHuPH20: 1129 infusions', 'unitOfMeasure': 'Percentage of infusions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Rate of Temporally Associated AEs Per Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.50'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.31'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.40'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Rate of all AEs (including and excluding infections) per infusion that began during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of an infusion ("temporally associated")', 'unitOfMeasure': 'Number of AEs per infusion', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set (SADS)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting ≥1 Temporally Associated AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '86.4', 'groupId': 'OG001'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}, {'value': '82.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of participants reporting at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated")', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Infusions Resulting in ≥1 Temporally Associated AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}, {'value': '24.5', 'groupId': 'OG001'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of infusions resulting in at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated")', 'unitOfMeasure': 'Percentage of infusions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up', 'description': 'Includes 2 participants who withdrew during ramp-up SC and rHuPH20 administration of IGIV, 10%'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}, {'value': '54.3', 'groupId': 'OG001'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of participants reporting at least 1 Moderate or Severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated")', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.1'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of infusions resulting in at least 1 moderate or severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated")', 'unitOfMeasure': 'Percentage of infusions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Administration of IGIV, 10% With rHuPH20 at Ramp-up', 'description': 'At start of SC administration of IGIV, 10% with rHuPH20, the first SC dose was a 1-week dose given for a 1-week interval, then if the 1 week SC infusions were tolerated, each week the interval (and dose) was increased by 1 week, until the treatment interval was the same as the interval for intravenous treatment (3 weeks or 4 weeks)'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During infusion or within 60 minutes of completion of the infusion', 'description': 'Percentage of subcutaneous (SC) doses of immune globulin intravenous (IGIV), 10% and recombinant human hyaluronidase (rHuPH20) tolerated at 1 infusion site. An infusion was deemed as tolerated if there were no serious adverse drug reactions (ADRs), no non-serious moderate or severe local ADRs that prevented completion of the infusion, and no non-serious moderate or severe systemic ADRs during or within 60 minutes of completion of the infusion.', 'unitOfMeasure': 'Percentage of infusions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '25.0'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '12.5'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '25.0'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of intravenous (IV) and subcutaneous (SC) infusions associated with ≥1 systemic AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via IV or SC route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion', 'unitOfMeasure': 'Percentage of infusions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000'}, {'value': '75.3', 'groupId': 'OG001'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000'}, {'value': '67.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of participants with ≥1 systemic AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants exposed to either or both study drugs'}, {'type': 'SECONDARY', 'title': 'Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.3'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of IV and SC (with recombinant human hyaluronidase \\[rHuPH20\\]) infusions associated with ≥1 local AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with rHuPH20 after ramp-up (during infusion) or within 72 hours of completion of infusion', 'unitOfMeasure': 'Percentage of infusions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.3'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At any time during the study', 'description': 'Percentage of intravenous (IV) and subcutaneous (SC) infusions with recombinant human hyaluronidase (rHuPH20) after ramp-up of immune globulin intravenous (IGIV), 10% associated with ≥1 local AE (including and excluding infections) at any time during the study', 'unitOfMeasure': 'Percentage of infusions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage 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'SECONDARY', 'title': 'Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.50'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.31'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.50'}, {'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.26'}]}]}], 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Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Abdominal Discomfort-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Distension-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Hernia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Lower-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Tenderness-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Tenderness-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Tenderness-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Acarodermatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Acne-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Acute Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acute Sinusitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Adenoidal Hypertrophy-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Adnexa Uteri Cyst-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adrenocortical Insufficiency Acute-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Allergic Respiratory Symptom-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Allergic Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alopecia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Animal Bite-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Antibody Test Positive-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aphthous Stomatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Aphthous Stomatitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Arteriosclerosis Coronary Artery-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Arthritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Arthropathy-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Arthropod Bite-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Arthropod Sting-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Arthropod Sting-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspiration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Asthma-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Asthma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Asthma-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Back Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Back Injury-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Back Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Back Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Bacterial Prostatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blepharitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blister-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Decreased-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Decreased-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'BP Systolic Increased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Increased-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Body Fat Disorder-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Body Tinea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Body Tinea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bone Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Breast Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchal Hyperreactivity-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchospasm-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Burn Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Burning Sensation-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Burning Sensation-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Burning Sensation-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bursitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bursitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Candidiasis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Candidiasis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Murmur-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cellulitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cellulitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cellulitis-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cerumen Impaction-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cervical Dysplasia-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cheilitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chest Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'COPD-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'COPD-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chronic Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Chronic Sinusitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Concussion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Confusional State-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Confusional State-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Allergic-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Allergic-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Bacterial-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Bacterial-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Bacterial-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Constipation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Contusion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Contusion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Contusion-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Coombs Test Positive-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Costochondritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cough-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Cough-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cough-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cushingoid-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cystitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Deafness Neurosensory-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Appetite-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Appetite-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Appetite-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dehydration-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dental Caries-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dental Caries-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Depressed Mood-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Depression-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dermal Cyst-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Acneiform-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Contact-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Contact-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Infected-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Infected-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Infected-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Device Failure-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Device Failure-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea Haemorrhagic-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea Infectious-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Dysfunction-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Disaccharide Metabolism Disorder-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Disturbance in Attention-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Diverticulitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Drug Eruption-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dry Eye-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dry Mouth-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dry Skin-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Dysmenorrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dyspepsia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dyspepsia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dyspepsia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dysuria-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ear Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ear Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ear Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ear Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ecchymosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eczema-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eczema-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eczema-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophil Count-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Epitaxis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Epitaxis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eustachian Tube Dysfunction-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Excoriation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Extravasation Blood-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eye Irritation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eye Pruritus-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eye Swelling-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fall-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fall-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Feeling Abnormal-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Feeling Cold-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Food Poisoning-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Free Haemoglobin Present-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Free Haemoglobin Present-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease', 'unitOfMeasure': 'Number of AEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Gait Disturbance-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Bacterial-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Viral-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Viral-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Viral-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Haemorrhage-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gastrooesophageal Reflux Disease-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Gastrooesophageal Reflux Disease-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genital Herpes-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genital Swelling-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Goitre-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gout-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grand Mal Convulsion-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grand Mal Convulsion-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gravitational Oedema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Groin Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Groin Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Groin Pain-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Haematoma-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Haematoma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Haematuria-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin Abnormal-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Haemorrhoids-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hand Fracture-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Headache-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hearing Impaired-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate Increased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heat Rash-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Heat Stroke-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Herpes Simplex Ophthalmic-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Herpes Zoster-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hiatus Hernia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hot Flush-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperaesthesia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypercholesterolaemia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkeratosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypertonia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypothyroidism-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Idiopathic Urticaria-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Increased Upper Airway Secretion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infected Bites-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Infected Bites-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Influenza-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Influenza-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Influenza Like Illness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Extravasation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Haematoma-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Haemorrhage-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Hypersensitivity-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Hypersensitivity-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Mass-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Mass-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Oedema-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Oedema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, Rboth, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Reaction-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Reaction-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, Rboth, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Warmth-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ingrowing Nail-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Erythema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Intervertebral Disc Protrusion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Irritable Bowel Syndrome-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Irritable Bowel Syndrome-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Joint Effusion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Joint Effusion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Joint Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Joint Range of Motion Decreased-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Joint Sprain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Joint Sprain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Joint Swelling-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Jugular Vein Distension-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lethargy-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lethargy-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ligament Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ligament Sprain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Limb Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lip Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lip Ulceration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Local Swelling-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Local Swelling-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Localised Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Localised Oedema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Localised Oedema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lung Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lung Infection-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Gland Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Node Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Node Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Node Palpable-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Lymphangitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte Count Decreased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphoedema-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Memory Impairment-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Molluscum Contagiosum-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mouth Ulceration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Multiple Sclerosis Relapse-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Fatigue-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Spasms-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Spasms-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Strain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Strain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Muscular Weakness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Chest Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Stiffness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe', 'unitOfMeasure': 'Number of AEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Nasal Congestion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Congestion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Congestion-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Discomfort-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Mucosal Discolouration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Turbinate Hypertrophy-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nasopharyngitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Neck Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Night Sweats-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Night Sweats-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nodule-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Oedema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Genital-non-SAE, Rboth, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Peripheral-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Peripheral-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Peripheral-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Oesophagitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Onychomycosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oral Candidiasis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oral Fungal Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oral Herpes-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Oral Herpes-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oral Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oral Pain-non-SAE, RrHu, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oropharyngeal Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Oropharyngeal Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Osteoarthritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Osteopenia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Osteopenia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Osteoporosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Externa-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Externa-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Media-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Palpitations-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Papule-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Peptic Ulcer Haemorrhage-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Periorbital Haematoma-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral Nerve Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pertussis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Petit Mal Epilepsy-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngeal Erythema-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngitis Streptococcal-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia Bacterial-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Post Procedural Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Post Procedural Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Postictal Paralysis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Postoperative Wound Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Procedural Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Procedural Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Productive Cough-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus Generalized-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pseudomonas Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Psoriasis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Rales-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rales-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Rash-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash Erythematous-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash Macro-Papular-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash Pustular-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash Pustular-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rash Papular-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Failure-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate Increased-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Congestion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Infection Viral-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rhinitis Allergic-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Rhinitis Allergic-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rhinitis Allergic-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rhinorrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Road Traffic Accident-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Scleritis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Scleritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Scratch-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Seborrhoeic Dermatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sicca Syndrome-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sinus Congestion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sinus Headache-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skeletal Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skeletal Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skin Hyperpigmentation-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skin Laceration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skin Laceration-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skin Lesion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skin Lesion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin Lesion-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Skin Papilloma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Spinal Osteoarthritis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Squamous Cell Carcinoma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Status Epilepticus-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal Ideation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sunburn-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Swelling-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Swelling-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Syncope-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tachycardia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Tachycardia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Therapy Cessation-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tinea Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tongue Coated-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tonsillar Hypertrophy-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tonsillar Hypertrophy-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Abscess-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Abscess-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Impacted-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Toothache-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tongue Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tremor-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tricuspid Valve Incompetence-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic Membrane Disorder-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic Membrane Hyperaemia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Upper Airway Cough Syndrome-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Upper Resp. Tract Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Upper Resp. Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Tract Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Urine Analysis Abnormal-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uterine Polyp-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal Haemorrhage-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Access Complication-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vertigo-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Viral Diarrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Viral Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Viral Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Viral Infection-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Viral Upper Resp. Tract Infection-non-SAE, NR Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Viral Upper Resp. Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vision Blurred-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D Deficiency-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D Deficiency-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vulvovaginal Pruritus-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Weight Decreased-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Weight Decreased-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Wheezing-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'WBC Count Decreased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Urine Positive-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'WBC Urine Positive-non-SAE, RIGIV Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells', 'unitOfMeasure': 'Number of AEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Abdominal Discomfort-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Distension-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Hernia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Lower-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Tenderness-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Tenderness-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Tenderness-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Acarodermatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Acne-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Acute Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acute Sinusitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Adenoidal Hypertrophy-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Adnexa Uteri Cyst-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adrenocortical Insufficiency Acute-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Allergic Respiratory Symptom-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Allergic Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alopecia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Animal Bite-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Antibody Test Positive-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aphthous Stomatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Aphthous Stomatitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Arteriosclerosis Coronary Artery-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Arthritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Arthropathy-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Arthropod Bite-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Arthropod Sting-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Arthropod Sting-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspiration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Asthma-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Asthma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.022', 'groupId': 'OG000'}, {'value': '0.019', 'groupId': 'OG001'}]}]}, {'title': 'Asthma-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Back Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Back Injury-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Back Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Back Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Bacterial Prostatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Blepharitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blister-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Decreased-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Decreased-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'BP Systolic Increased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Increased-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Body Fat Disorder-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Body Tinea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Body Tinea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Bone Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Breast Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchal Hyperreactivity-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.007', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchospasm-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Burn Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Burning Sensation-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Burning Sensation-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Burning Sensation-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Bursitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bursitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Candidiasis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Candidiasis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Murmur-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Cellulitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Cellulitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Cellulitis-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Cerumen Impaction-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Cervical Dysplasia-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Cheilitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chest Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.016', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'COPD-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'COPD-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chronic Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Chronic Sinusitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Concussion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Confusional State-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Confusional State-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Allergic-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Allergic-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Bacterial-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Bacterial-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Bacterial-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Constipation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Contusion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Contusion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Contusion-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Coombs Test Positive-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Costochondritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Cough-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000'}, {'value': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Cough-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Cough-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cushingoid-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Cystitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Deafness Neurosensory-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Appetite-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Appetite-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Appetite-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Dehydration-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Dental Caries-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Dental Caries-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Depressed Mood-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Depression-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Dermal Cyst-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Acneiform-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Contact-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Contact-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Infected-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Infected-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Infected-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Device Failure-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Device Failure-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000'}, {'value': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea Haemorrhagic-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea Infectious-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Dysfunction-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Disaccharide Metabolism Disorder-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Disturbance in Attention-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Diverticulitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.006', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Drug Eruption-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dry Eye-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Dry Mouth-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Dry Skin-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Dysmenorrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Dyspepsia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Dyspepsia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Dyspepsia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dysuria-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Ear Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Ear Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Ear Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Ear Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Ecchymosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Eczema-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Eczema-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Eczema-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophil Count-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Epitaxis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Epitaxis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Eustachian Tube Dysfunction-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Excoriation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Extravasation Blood-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Eye Irritation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Eye Pruritus-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Eye Swelling-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Fall-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Fall-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.022', 'groupId': 'OG000'}, {'value': '0.007', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Feeling Abnormal-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Feeling Cold-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Food Poisoning-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Free Haemoglobin Present-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Free Haemoglobin Present-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease', 'unitOfMeasure': 'Number of AEs per infusion', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Gait Disturbance-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Bacterial-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Viral-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000'}, {'value': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Viral-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Viral-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Haemorrhage-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Gastrooesophageal Reflux Disease-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Gastrooesophageal Reflux Disease-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genital Herpes-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genital Swelling-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Goitre-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gout-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Grand Mal Convulsion-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grand Mal Convulsion-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Gravitational Oedema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Groin Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Groin Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Groin Pain-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Haematoma-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Haematoma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Haematuria-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin Abnormal-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Haemorrhoids-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Hand Fracture-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.036', 'groupId': 'OG000'}, {'value': '0.014', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.068', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.033', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.008', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.007', 'groupId': 'OG001'}]}]}, {'title': 'Headache-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Hearing Impaired-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate Increased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heat Rash-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Heat Stroke-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Herpes Simplex Ophthalmic-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Herpes Zoster-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Hiatus Hernia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Hot Flush-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperaesthesia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Hypercholesterolaemia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkeratosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Hypertonia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Hypothyroidism-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Idiopathic Urticaria-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Increased Upper Airway Secretion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infected Bites-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Infected Bites-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Influenza-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Influenza-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Influenza Like Illness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.013', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.007', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.018', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Extravasation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Haematoma-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Haemorrhage-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Hypersensitivity-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Hypersensitivity-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Mass-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Mass-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Oedema-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Oedema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.011', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.014', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, Rboth, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Reaction-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Reaction-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, Rboth, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Warmth-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Ingrowing Nail-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Erythema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Intervertebral Disc Protrusion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Irritable Bowel Syndrome-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Irritable Bowel Syndrome-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Joint Effusion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Joint Effusion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Joint Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Joint Range of Motion Decreased-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Joint Sprain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Joint Sprain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Joint Swelling-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Jugular Vein Distension-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Lethargy-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Lethargy-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ligament Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Ligament Sprain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Limb Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lip Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Lip Ulceration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Local Swelling-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Local Swelling-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Localised Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Localised Oedema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Localised Oedema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Lung Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lung Infection-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Gland Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Node Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Node Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Node Palpable-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.007', 'groupId': 'OG001'}]}]}, {'title': 'Lymphangitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte Count Decreased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Lymphoedema-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Memory Impairment-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Molluscum Contagiosum-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mouth Ulceration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Multiple Sclerosis Relapse-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Fatigue-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Spasms-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Spasms-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Strain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Strain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Muscular Weakness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Chest Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Stiffness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe', 'unitOfMeasure': 'Number of AEs per infusion', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Nasal Congestion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Congestion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Congestion-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Discomfort-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Mucosal Discolouration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Turbinate Hypertrophy-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Nasopharyngitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.007', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000'}, {'value': '0.015', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.019', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Neck Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Night Sweats-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Night Sweats-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Nodule-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Oedema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Genital-non-SAE, Rboth, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Peripheral-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Peripheral-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Peripheral-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Oesophagitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Onychomycosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Oral Candidiasis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Oral Fungal Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Oral Herpes-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Oral Herpes-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Oral Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Oral Pain-non-SAE, RrHu, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Oropharyngeal Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Oropharyngeal Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Osteoarthritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Osteopenia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Osteopenia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Osteoporosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Externa-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Externa-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Media-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Palpitations-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Papule-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Peptic Ulcer Haemorrhage-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Periorbital Haematoma-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral Nerve Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pertussis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Petit Mal Epilepsy-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngeal Erythema-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngitis Streptococcal-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia Bacterial-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Post Procedural Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Post Procedural Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Postictal Paralysis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Postoperative Wound Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Procedural Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Procedural Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Productive Cough-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus Generalized-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pseudomonas Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Psoriasis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000'}, {'value': '0.010', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Rales-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Rales-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Rash-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Rash-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Rash Erythematous-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Rash Maculo-Papular-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Rash Pustular-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Rash Pustular-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rash Papular-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Failure-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate Increased-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Congestion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Infection Viral-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rhinitis Allergic-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Rhinitis Allergic-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Rhinitis Allergic-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rhinorrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Road Traffic Accident-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Scleritis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Scleritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Scratch-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Seborrhoeic Dermatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Sicca Syndrome-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Sinus Congestion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sinus Headache-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.016', 'groupId': 'OG000'}, {'value': '0.022', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.036', 'groupId': 'OG000'}, {'value': '0.023', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Skeletal Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Skeletal Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Skin Hyperpigmentation-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Skin Laceration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Skin Laceration-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Skin Lesion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Skin Lesion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin Lesion-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Skin Papilloma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Spinal Osteoarthritis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Squamous Cell Carcinoma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Status Epilepticus-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal Ideation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sunburn-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Swelling-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Swelling-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Syncope-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tachycardia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Tachycardia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Therapy Cessation-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tinea Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tongue Coated-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tonsillar Hypertrophy-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tonsillar Hypertrophy-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Abscess-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Abscess-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Impacted-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Toothache-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tongue Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tremor-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tricuspid Valve Incompetence-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic Membrane Disorder-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic Membrane Hyperaemia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Upper Airway Cough Syndrome-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Upper Resp. Tract Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.019', 'groupId': 'OG000'}, {'value': '0.030', 'groupId': 'OG001'}]}]}, {'title': 'Upper Resp. Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000'}, {'value': '0.009', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Tract Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.014', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Urine Analysis Abnormal-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uterine Polyp-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal Haemorrhage-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Access Complication-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vertigo-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Viral Diarrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Viral Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0008', 'groupId': 'OG000'}, {'value': '0.006', 'groupId': 'OG001'}]}]}, {'title': 'Viral Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.008', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Viral Infection-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Viral Upper Resp. Tract Infection-non-SAE, NR Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.007', 'groupId': 'OG001'}]}]}, {'title': 'Viral Upper Resp. Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Vision Blurred-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D Deficiency-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D Deficiency-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.014', 'groupId': 'OG000'}, {'value': '0.006', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.003', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Vulvovaginal Pruritus-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Weight Decreased-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Weight Decreased-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Wheezing-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'WBC Count Decreased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Urine Positive-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'WBC Urine Positive-non-SAE, RIGIV Mild', 'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); ; RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells', 'unitOfMeasure': 'Number of AEs per infusion', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Abdominal Discomfort-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Distension-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Hernia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Lower-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain Upper-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Tenderness-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Tenderness-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Tenderness-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Acarodermatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Acne-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Acute Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acute Sinusitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Adenoidal Hypertrophy-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Adnexa Uteri Cyst-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adrenocortical Insufficiency Acute-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Allergic Respiratory Symptom-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Allergic Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alopecia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Animal Bite-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Antibody Test Positive-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aphthous Stomatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Aphthous Stomatitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Arteriosclerosis Coronary Artery-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Arthritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Arthropathy-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Arthropod Bite-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Arthropod Sting-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Arthropod Sting-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspiration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Asthma-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Asthma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.092', 'groupId': 'OG000'}, {'value': '0.259', 'groupId': 'OG001'}]}]}, {'title': 'Asthma-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'ADHD-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Back Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Back Injury-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Back Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Back Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Bacterial Prostatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Blepharitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blister-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Decreased-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Decreased-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Blood Pressure Increased-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'BP Systolic Increased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Increased-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Body Fat Disorder-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Body Tinea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Body Tinea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Bone Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Breast Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchal Hyperreactivity-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.046', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchospasm-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Burn Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Burning Sensation-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Burning Sensation-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Burning Sensation-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Bursitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bursitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Candidiasis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Candidiasis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Murmur-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Cellulitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Cellulitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Cellulitis-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Cerumen Impaction-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Cervical Dysplasia-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Cheilitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chest Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.069', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chills-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'COPD-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'COPD-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chronic Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Chronic Sinusitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Concussion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Confusional State-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Confusional State-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Allergic-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Allergic-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Bacterial-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Bacterial-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis Bacterial-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Constipation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Contusion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Contusion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Contusion-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Coombs Test Positive-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Costochondritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Cough-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Cough-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Cough-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cushingoid-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Cystitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Deafness Neurosensory-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Appetite-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Appetite-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Appetite-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Dehydration-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Dental Caries-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Dental Caries-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Depressed Mood-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Depression-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Dermal Cyst-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Acneiform-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Contact-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Contact-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Infected-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Infected-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis Infected-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Device Failure-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Device Failure-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea Haemorrhagic-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea Infectious-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Dysfunction-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Disaccharide Metabolism Disorder-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Disturbance in Attention-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Diverticulitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.086', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Drug Eruption-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dry Eye-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Dry Mouth-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Dry Skin-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Dysmenorrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Dyspepsia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Dyspepsia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Dyspepsia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dysuria-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Ear Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Ear Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Ear Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Ear Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Ecchymosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Eczema-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Eczema-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Eczema-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophil Count-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Epitaxis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Epitaxis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Eustachian Tube Dysfunction-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Excoriation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.025', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Extravasation Blood-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Eye Irritation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Eye Pruritus-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Eye Swelling-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Fall-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Fall-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.092', 'groupId': 'OG000'}, {'value': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Feeling Abnormal-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Feeling Cold-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Food Poisoning-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Free Haemoglobin Present-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Free Haemoglobin Present-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease', 'unitOfMeasure': 'Number of AEs per participant', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Gait Disturbance-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Bacterial-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Viral-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Viral-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Gastroenteritis Viral-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Haemorrhage-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Gastrooesophageal Reflux Disease-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Gastrooesophageal Reflux Disease-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genital Herpes-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genital Swelling-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Goitre-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gout-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Grand Mal Convulsion-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grand Mal Convulsion-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Gravitational Oedema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Groin Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Groin Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Groin Pain-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Haematoma-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Haematoma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Haematuria-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin Abnormal-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Haemorrhoids-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Hand Fracture-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.149', 'groupId': 'OG000'}, {'value': '0.198', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.287', 'groupId': 'OG000'}, {'value': '0.173', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.138', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.011', 'groupId': 'OG001'}]}]}, {'title': 'Headache-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Headache-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Hearing Impaired-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate Increased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.046', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heat Rash-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Heat Stroke-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Herpes Simplex Ophthalmic-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Herpes Zoster-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Hiatus Hernia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Hot Flush-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperaesthesia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Hypercholesterolaemia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkeratosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Hypertonia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Hypothyroidism-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Idiopathic Urticaria-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Increased Upper Airway Secretion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infected Bites-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Infected Bites-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Influenza-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Influenza-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.046', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Influenza Like Illness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Related Reaction-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.185', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Discomfort-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.247', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Erythema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Extravasation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Haematoma-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Haemorrhage-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Hypersensitivity-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Hypersensitivity-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Mass-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Mass-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Oedema-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Oedema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.148', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.432', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.235', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.198', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pain-non-SAE, Rboth, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Pruritus-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Reaction-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Reaction-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Swelling-non-SAE, Rboth, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Infusion Site Warmth-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Ingrowing Nail-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Erythema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Intervertebral Disc Protrusion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Irritable Bowel Syndrome-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Irritable Bowel Syndrome-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Joint Effusion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Joint Effusion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Joint Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Joint Range of Motion Decreased-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Joint Sprain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Joint Sprain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Joint Swelling-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Jugular Vein Distension-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Lethargy-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Lethargy-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.011', 'groupId': 'OG001'}]}]}, {'title': 'Ligament Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Ligament Sprain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Limb Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lip Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Lip Ulceration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Local Swelling-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Local Swelling-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Localised Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Localised Oedema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Localised Oedema-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Lung Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lung Infection-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Gland Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Node Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Node Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Node Palpable-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Lymphangitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte Count Decreased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Lymphoedema-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Memory Impairment-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Migraine-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Molluscum Contagiosum-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mouth Ulceration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Multiple Sclerosis Relapse-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Fatigue-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Spasms-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Spasms-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Strain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Muscle Strain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Muscular Weakness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Chest Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal Stiffness-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe', 'unitOfMeasure': 'Number of AEs per participant', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Nasal Congestion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.046', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Congestion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Congestion-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Discomfort-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Mucosal Discolouration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Turbinate Hypertrophy-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Nasopharyngitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.046', 'groupId': 'OG000'}, {'value': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0.210', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.080', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Neck Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Night Sweats-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Night Sweats-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Nodule-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Oedema-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Genital-non-SAE, Rboth, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Peripheral-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Peripheral-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Oedema Peripheral-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Oesophagitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Onychomycosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Oral Candidiasis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Oral Fungal Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Oral Herpes-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Oral Herpes-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Oral Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Oral Pain-non-SAE, RrHu, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Oropharyngeal Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Oropharyngeal Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Osteoarthritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Osteopenia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Osteopenia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Osteoporosis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Externa-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Externa-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Media-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pain-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Pain in Extremity-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Palpitations-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Papule-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Peptic Ulcer Haemorrhage-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Periorbital Haematoma-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral Nerve Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pertussis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Petit Mal Epilepsy-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngeal Erythema-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngitis Streptococcal-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia Bacterial-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Post Procedural Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Post Procedural Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Postictal Paralysis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Postoperative Wound Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Procedural Pain-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Procedural Pain-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Productive Cough-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus Generalized-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pseudomonas Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Psoriasis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0.136', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.046', 'groupId': 'OG000'}, {'value': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Rales-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Rales-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Rash-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Rash-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Rash Erythematous-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Rash Maculo-Papular-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Rash Pustular-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Rash Pustular-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rash Papular-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Failure-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate Increased-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Congestion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Infection Viral-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rhinitis Allergic-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Rhinitis Allergic-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Rhinitis Allergic-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rhinorrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Road Traffic Accident-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Scleritis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Scleritis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Scratch-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Seborrhoeic Dermatitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Sicca Syndrome-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Sinus Congestion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sinus Headache-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.069', 'groupId': 'OG000'}, {'value': '0.309', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.149', 'groupId': 'OG000'}, {'value': '0.321', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Skeletal Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Skeletal Injury-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Skin Hyperpigmentation-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Skin Laceration-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Skin Laceration-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Skin Lesion-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Skin Lesion-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin Lesion-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Skin Papilloma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Spinal Osteoarthritis-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Squamous Cell Carcinoma-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Status Epilepticus-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal Ideation-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sunburn-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Swelling-non-SAE, Rboth, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Swelling-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Syncope-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tachycardia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.037', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tachycardia-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Therapy Cessation-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis-non-SAE, NR, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tinea Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.023', 'groupId': 'OG001'}]}]}, {'title': 'Tongue Coated-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tonsillar Hypertrophy-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tonsillar Hypertrophy-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Abscess-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Abscess-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Impacted-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tooth Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Toothache-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tongue Injury-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tremor-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tricuspid Valve Incompetence-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic Membrane Disorder-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic Membrane Hyperaemia-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Upper Airway Cough Syndrome-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Upper Resp. Tract Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.080', 'groupId': 'OG000'}, {'value': '0.420', 'groupId': 'OG001'}]}]}, {'title': 'Upper Resp. Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}, {'value': '0.123', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Tract Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.057', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Urine Analysis Abnormal-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uterine Polyp-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal Haemorrhage-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Access Complication-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vertigo-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Viral Diarrhoea-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Viral Infection-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0.086', 'groupId': 'OG001'}]}]}, {'title': 'Viral Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Viral Infection-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Viral Upper Resp. Tract Infection-non-SAE, NR Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Viral Upper Resp. Tract Infection-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Vision Blurred-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D Deficiency-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D Deficiency-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0.057', 'groupId': 'OG000'}, {'value': '0.096', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0.046', 'groupId': 'OG000'}, {'value': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, RIGIV, Mod', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, RIGIV, Severe', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting-non-SAE, Rboth, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Vulvovaginal Pruritus-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Weight Decreased-non-SAE, RrHu, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Weight Decreased-non-SAE, RrHu, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'Wheezing-non-SAE, NR, Mod', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'WBC Count Decreased-non-SAE, RIGIV, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Urine Positive-non-SAE, NR, Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.012', 'groupId': 'OG001'}]}]}, {'title': 'WBC Urine Positive-non-SAE, RIGIV Mild', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells', 'unitOfMeasure': 'Number of AEs per participant', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 With Ramp-up'}], 'classes': [{'title': 'Including infections', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '25.0'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '20.8'}]}]}, {'title': 'Excluding infections', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '25.0'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '20.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Percentage of Infusions Associated With ≥1 AE Related to immune globulin intravenous (IGIV), 10%, \\[administered via intravenous (IV) or subcutaneous (SC) route\\], recombinant human hyaluronidase (rHuPH20) or both. The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed.', 'unitOfMeasure': 'Percentage of infusions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Epoch 2: subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10% with recombinant human hyaluronidase (rHuPH20) after ramp-up. Dose used in Epoch 2 (after ramp-up) was 108% of dose used in intravenous (IV) administration of IGIV, 10%. The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed.', 'unitOfMeasure': 'Percentage of infusions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Administration of IGIV, 10%'}, {'id': 'OG001', 'title': 'SC Administration of IGIV, 10% With rHuPH20 After Ramp-up'}], 'classes': [{'title': 'Including Infections', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.50'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.31'}]}]}, {'title': 'Excluding Infections', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.50'}, {'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Temporally associated defined as during infusion or within 72 hours of completion of infusion. Related defined as determined by investigator to be at least possibly related to study drug (immune globulin intravenous \\[IGIV\\], 10% or recombinant human hyaluronidase \\[rHuPH20\\]). Expressed as a percentage.', 'unitOfMeasure': 'Percentage of AE', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Infusions', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Administration of IGIV, 10% With rHuPH20'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants in Safety Data Analysis Set', 'description': 'Participants exposed to either or both study drugs'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': "Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis", 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants in Safety Data Analysis Set', 'description': 'Participants exposed to either or both study drugs'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (17 months)', 'description': "Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2 to <12 Years', 'description': 'The same as the other study arm/group (please see "12 Years and Older", due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to \\<12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children.'}, {'id': 'FG001', 'title': '12 Years and Older', 'description': 'EPOCH 1: Pharmacokinetics (PK) of intravenous (IV) administration of immune globulin intravenous (IGIV), 10%. Participants who previously participated in Study 160601 entered this study directly to Epoch 2 ramp-up. PK data collected during IV treatment in Study 160601 was compared with PK data from subcutaneous (SC) treatment during this study. EPOCH 2 RAMP-UP ("ramp-up"):Treatment intervals/ doses used for initial SC infusions of IGIV, 10% were slowly increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. Prior to SC infusions, recombinant human hyaluronidase (rHuPH20) was administered at a minimum dose of 75 U/g IgG. EPOCH 2 after RAMP-UP: Participants were treated SC with IGIV, 10% with rHuPH20 at 108% of IV dose from Epoch 1 (or from study 160601). Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.'}], 'periods': [{'title': 'Epoch 1 (IV Treatment)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant missed 2 consecutive doses', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Between Epoch 1 (IV) and Epoch 2 Ramp-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Epoch 2 Ramp-up ("Ramp-up")', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Geographic Factor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Epoch 2 After Ramp-up (SC/rHuPH20)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'comment': 'Three participants who switched to safety follow-up remained in the study.', 'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject Felt Increased Infections on SC', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Switched to safety follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment was conducted 14 clinical sites in the United States and 1 clinical site in Canada.', 'preAssignmentDetails': '89 participants who enrolled were screened. Of these, 2 withdrew before treatment (both were screen failures)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '2 to <12 Years', 'description': 'The same as the other study arm/group (please see "12 Years and Older", due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to \\<12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children.'}, {'id': 'BG001', 'title': '12 Years and Older', 'description': 'EPOCH 1: Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of Subcutaneous (SC) infusions Recombinant human hyaluronidase (rHuPH20) + immune globulin intravenous (IGIV). Participants who previously participated in Study 160601 entered this study at Epoch 2. PK data collected during IV treatment in Study 160601 were used for comparison with PK data from SC treatment during this study (160603). EPOCH 2: (ramp-up and After ramp-up). Participants were treated SC with GAMMAGARD LIQUID/KIOVIG at 108% of IV dose from Epoch 1 or Study 160601. 108% was derived from PK data from Study 160602. Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG. Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment (ramp-up), to allow participants to adjust to increasing volume administered SC. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '11'}, {'value': '44.0', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '78'}, {'value': '35.0', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2011-11-30', 'completionDateStruct': {'date': '2010-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-30', 'studyFirstSubmitDate': '2008-12-23', 'dispFirstSubmitQcDate': '2011-11-30', 'resultsFirstSubmitDate': '2015-01-21', 'studyFirstSubmitQcDate': '2008-12-23', 'dispFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-30', 'studyFirstPostDateStruct': {'date': '2008-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validated Acute Serious Bacterial Infection (VASBI) Rate', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen. VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only. The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant.'}], 'secondaryOutcomes': [{'measure': 'Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years', 'timeFrame': 'PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion', 'description': 'Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of ratio of Area Under the Concentration Curve (AUC)/Week after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.'}, {'measure': 'Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years', 'timeFrame': 'IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit', 'description': 'Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of trough levels after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.'}, {'measure': 'Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20', 'timeFrame': 'PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf.', 'description': 'Bioavailability of immunoglobulin (IgG) after subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10%, with and without recombinant human hyaluronidase (rHuPH20) (from current study 160603 and study 160601, respectively), as measured by ratio of AUC of IgG per dose/kg with versus without rHuPH20. Expressed as a percentage. This was analysed for participants in Stratum A , participants in Stratum B and for all participants who received IGIV, 10% via SC administration (Stratum A plus Stratum B): Stratum A: Participants who provided data both on SC with AND without rHuPH20 ie, participants who participated in both studies 160601 and 160603; Stratum B: Participants who provided data on SC with OR without rHuPH20, but not on both (participants who participated in study 160601 OR 160603, but not in both studies).'}, {'measure': 'Annual Rate of All Infections Per Participant', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Annual rate of all infections per participant after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the annual rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary endpoint.'}, {'measure': 'Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20', 'timeFrame': 'IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit.', 'description': 'Trough levels of immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up'}, {'measure': 'Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20', 'timeFrame': 'IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit', 'description': 'Trough levels of immunoglobulin (IgG) subclasses after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up by IgG subclasses 1 to 4 at end of IV treatment and end of SC treatment with rHuPH20 IgG subclass 1 (IgG 1) IgG subclass 2 (IgG 2) IgG subclass 3 (IgG 3) IgG subclass 4 (IgG 4)'}, {'measure': 'Antibody Levels to Tetanus (Clostridium Tetani Toxoid)', 'timeFrame': 'IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit', 'description': 'Antibody levels to Tetanus (Clostridium tetani toxoid) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20'}, {'measure': 'Antibody Levels to Haemophilus Influenzae', 'timeFrame': 'IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit', 'description': 'Antibody levels to Haemophilus influenzae after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20'}, {'measure': 'Antibody Levels to Measles', 'timeFrame': 'IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit', 'description': 'Antibody levels to measles after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20'}, {'measure': 'Antibody Levels to Hepatitis B', 'timeFrame': 'IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit', 'description': 'Antibody levels to hepatitis B after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20'}, {'measure': 'IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion', 'description': 'Minimal immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and Older'}, {'measure': 'IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Immunoglobulin (IgG) Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval).'}, {'measure': 'IgG Clearance (CL) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Immunoglobulin (IgG) Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance and apparent clearance are determined by weight adjusted dose divided by total AUC.'}, {'measure': 'IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Maximum immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older'}, {'measure': 'IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Terminal half life (T1/2) for immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50% during the terminal phase'}, {'measure': 'Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Time to Maximum Immunoglobulin (IgG) Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older'}, {'measure': 'Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Minimal tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older'}, {'measure': 'Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Tetanus (clostridium tetani toxoid) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval).'}, {'measure': 'Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Tetanus (clostridium tetani toxoid) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC.'}, {'measure': 'Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Terminal half life (T1/2) for tetanus (clostridium tetani toxoid) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of tetanus antibody in the body to be reduced by 50% during the terminal phase'}, {'measure': 'Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Maximum tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older'}, {'measure': 'Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Time to Maximum tetanus (clostridium tetani toxoid) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older'}, {'measure': 'H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Minimal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older'}, {'measure': 'H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Influenza (haemophilus influenzae) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval).'}, {'measure': 'H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Influenza (haemophilus influenzae) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC.'}, {'measure': 'H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Maximal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older'}, {'measure': 'H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Terminal half life (T1/2) for influenza (haemophilus influenzae) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of influenza antibody in the body to be reduced by 50% during the terminal phase.'}, {'measure': 'Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older', 'timeFrame': 'PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.', 'description': 'Time to Maximum influenza (haemophilus influenzae) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older'}, {'measure': 'Rate of Days Off School or Work', 'timeFrame': 'Monthly, for up to 17 months', 'description': 'Monthly rate of days off school or work after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month were defined as average length of the month in the Gregorian calendar, namely (365\\*400+100-3)/(400\\*12)= 30.436875 days.'}, {'measure': 'Rate of Days on Antibiotics', 'timeFrame': 'Monthly, for up to 17 months', 'description': 'Monthly rate of days on antibiotics after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month was defined as average length of the month in the Gregorian calendar, namely (365\\*400+100-3)/(400\\*12)= 30.436875 days.'}, {'measure': 'Rate of Acute Physician Visits', 'timeFrame': 'Monthly, for up to 17 months', 'description': 'Monthly rate of acute physician visits after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365\\*400+100-3)/(400\\*12)= 30.436875 days.'}, {'measure': 'Rate of Days in Hospital', 'timeFrame': 'Monthly, for up to 17 months', 'description': 'Monthly rate of days in hospital after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365\\*400+100-3)/(400\\*12)= 30.436875 days.'}, {'measure': 'Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Percentage of participants for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs). An infusion was deemed as tolerated if there are no serious Adverse Drug Reactions (ADR), no non-serious moderate or severe local ADRs that prevent completion of the infusion and no non-serious moderate or severe systemic ADRs during infusion or within 60 minutes of completion of the infusion.'}, {'measure': 'Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Percentage of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs). IV administration of IGIV, 10%: 365 infusions; SC administration of IGIV, 10% with rHuPH20: 1129 infusions'}, {'measure': 'Rate of Temporally Associated AEs Per Infusion', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Rate of all AEs (including and excluding infections) per infusion that began during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of an infusion ("temporally associated")'}, {'measure': 'Percentage of Participants Reporting ≥1 Temporally Associated AEs', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of participants reporting at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated")'}, {'measure': 'Percentage of Infusions Resulting in ≥1 Temporally Associated AEs', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of infusions resulting in at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated")'}, {'measure': 'Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of participants reporting at least 1 Moderate or Severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated")'}, {'measure': 'Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of infusions resulting in at least 1 moderate or severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated")'}, {'measure': 'Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site', 'timeFrame': 'During infusion or within 60 minutes of completion of the infusion', 'description': 'Percentage of subcutaneous (SC) doses of immune globulin intravenous (IGIV), 10% and recombinant human hyaluronidase (rHuPH20) tolerated at 1 infusion site. An infusion was deemed as tolerated if there were no serious adverse drug reactions (ADRs), no non-serious moderate or severe local ADRs that prevented completion of the infusion, and no non-serious moderate or severe systemic ADRs during or within 60 minutes of completion of the infusion.'}, {'measure': 'Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of intravenous (IV) and subcutaneous (SC) infusions associated with ≥1 systemic AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via IV or SC route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion'}, {'measure': 'Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of participants with ≥1 systemic AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion'}, {'measure': 'Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of IV and SC (with recombinant human hyaluronidase \\[rHuPH20\\]) infusions associated with ≥1 local AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with rHuPH20 after ramp-up (during infusion) or within 72 hours of completion of infusion'}, {'measure': 'Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study', 'timeFrame': 'At any time during the study', 'description': 'Percentage of intravenous (IV) and subcutaneous (SC) infusions with recombinant human hyaluronidase (rHuPH20) after ramp-up of immune globulin intravenous (IGIV), 10% associated with ≥1 local AE (including and excluding infections) at any time during the study'}, {'measure': 'Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of participants With ≥1 local AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion'}, {'measure': 'Percentage of Participants With ≥1 Local AE At Any Time During the Study', 'timeFrame': 'During infusion or within 72 hours of completion of infusion', 'description': 'Percentage of participants With ≥1 local AE (including and excluding infections) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up at any time during the study'}, {'measure': 'Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous \\[IGIV\\], 10% or recombinant human hyaluronidase \\[rHuPH20\\]), that occur at any time during the study divided by the total number of participants'}, {'measure': 'Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous \\[IGIV\\], 10% or recombinant human hyaluronidase \\[rHuPH20\\]), that occur at any time during the study divided by the total number of infusions'}, {'measure': 'Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Frequency of dose corrections based on immune globulin G (IgG) trough levels \\<4.5 g/L IgG, if any, for intravenous (IV) (Epoch 1) and subcutaneous with recombinant human hyaluronidase (SC/rHuPH20) after ramp-up (Epoch 2) administration of immune globulin intravenous (IGIV), 10% Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set.'}, {'measure': 'Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease'}, {'measure': 'Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe'}, {'measure': 'Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells'}, {'measure': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease'}, {'measure': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe'}, {'measure': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); ; RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells'}, {'measure': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease'}, {'measure': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe'}, {'measure': 'Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells'}, {'measure': 'Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Percentage of Infusions Associated With ≥1 AE Related to immune globulin intravenous (IGIV), 10%, \\[administered via intravenous (IV) or subcutaneous (SC) route\\], recombinant human hyaluronidase (rHuPH20) or both. The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed.'}, {'measure': 'Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment)', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Epoch 2: subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10% with recombinant human hyaluronidase (rHuPH20) after ramp-up. Dose used in Epoch 2 (after ramp-up) was 108% of dose used in intravenous (IV) administration of IGIV, 10%. The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed.'}, {'measure': 'Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion', 'timeFrame': 'Throughout the study period (17 months)', 'description': 'Temporally associated defined as during infusion or within 72 hours of completion of infusion. Related defined as determined by investigator to be at least possibly related to study drug (immune globulin intravenous \\[IGIV\\], 10% or recombinant human hyaluronidase \\[rHuPH20\\]). Expressed as a percentage.'}, {'measure': 'Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)', 'timeFrame': 'Throughout the study period (17 months)'}, {'measure': 'Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)', 'timeFrame': 'Throughout the study period (17 months)'}, {'measure': 'Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis', 'timeFrame': 'Throughout the study period (17 months)', 'description': "Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis"}, {'measure': 'Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis', 'timeFrame': 'Throughout the study period (17 months)', 'description': "Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Immunodeficiency Diseases (PID)']}, 'referencesModule': {'references': [{'pmid': '27220317', 'type': 'RESULT', 'citation': 'Wasserman RL, Melamed I, Stein MR, Engl W, Sharkhawy M, Leibl H, Puck J, Rubinstein A, Kobrynski L, Gupta S, Grant AJ, Ratnayake A, Richmond WG, Church J, Yel L, Gelmont D. Long-Term Tolerability, Safety, and Efficacy of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Human Immunoglobulin for Primary Immunodeficiency. J Clin Immunol. 2016 Aug;36(6):571-82. doi: 10.1007/s10875-016-0298-x. Epub 2016 May 25.'}, {'pmid': '22846381', 'type': 'RESULT', 'citation': 'Wasserman RL, Melamed I, Stein MR, Gupta S, Puck J, Engl W, Leibl H, McCoy B, Empson VG, Gelmont D, Schiff RI; IGSC, 10% with rHuPH20 Study Group. Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. J Allergy Clin Immunol. 2012 Oct;130(4):951-7.e11. doi: 10.1016/j.jaci.2012.06.021. Epub 2012 Jul 28.'}, {'pmid': '34931880', 'type': 'DERIVED', 'citation': 'Wasserman RL, Gupta S, Stein M, Rabbat CJ, Engl W, Leibl H, Yel L. Infection rates and tolerability of three different immunoglobulin administration modalities in patients with primary immunodeficiency diseases. Immunotherapy. 2022 Mar;14(4):215-224. doi: 10.2217/imt-2021-0256. Epub 2021 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to develop a subcutaneous treatment option for participants with Primary Immunodeficiency Diseases (PID) that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency as IV administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is 2 years or older at the time of screening\n* Written informed consent obtained from either the participant or the participant's legally acceptable representative prior to any study-related procedures and study product administration\n* Participant has been diagnosed with a PID disorder requiring antibody replacement as defined by WHO criteria\n* Participant has completed or is about to complete Baxter Clinical Study Protocol No. 160601 or has been receiving a regular IGIV-treatment at mean intervals of 21 ± 3 days or 28 ± 3 days, or SC at mean intervals of 5 to 16 days, over a period of at least 3 months prior to enrollment at a minimum dose of 300 mg/kg BW/4 weeks\n* Participant has a serum trough level of IgG \\> 4.5 g/L at the last documented determination\n* If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study\n* Participant is willing and able to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Participant has a known history of or is positive at enrollment or screening for one or more of the following: Hepatitis B surface antigen (HbsAg), polymerase chain reaction (PCR) for Hepatitis C Virus (HCV), PCR for Human immunodeficiency virus (HIV) Type 1/2\n* Participant has levels of alanine aminotransferase (ALT) or aspartate amino transferase (AST) \\> 2.5 times the upper limit of normal for the testing laboratory\n* Participant has persistent severe neutropenia (defined as an absolute neutrophil count \\[ANC\\] \\<= 500/mm3)\n* Participant has creatinine clearance (CLcr) values, calculated according to the formula below, which are \\< 60% of normal for age and gender for males: CLcr = \\[(140 - Age(years)) \\* (body weight (kg))\\] / \\[72 \\* (serum creatinine (mg/dL))\\] for females: CLcr = \\[(140 - Age(years)) \\* (body weight(kg)) \\* 0.85\\] / \\[72 \\* (serum creatinine (mg/dL))\\]\n* Participant has been diagnosed with, or has a malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within the last 12 months prior to enrollment; participants treated with immunosuppressive chemotherapeutic agents during this period are excluded\n* Participant has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months\n* Participant has abnormal protein loss (protein losing enteropathy, nephrotic syndrome)\n* Participant has anemia that would preclude phlebotomy for laboratory studies\n* Participant has received any blood or blood product other than an IGIV, SC immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to enrollment\n* Participant has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC immunoglobulin, and/or ISG infusions\n* Participant has immunoglobulin A (IgA) deficiency and known anti IgA antibodies\n* Participant is on preventative (prophylactic) antibiotics and cannot stop antibiotics at the time of enrollment\n* Participant has active infection who started on antibiotic therapy for the treatment of infection within 7 days prior to screening\n* Participant has a bleeding disorder or is on anti-coagulation therapy that results in a platelet count less than 20,000/μL or International Normalized Ration (INR) \\> 2X control, or who, in the opinion of the investigator would be at significant risk of increased bleeding or bruising as a result of SC therapy\n* Participant has total protein \\> 9 g/dL and participants with myeloma, macroglobulinemia (IgM) and paraproteinemia\n* Participant has a known allergy to hyaluronidase\n* If female, participant is pregnant or lactating at the time of study enrollment\n* Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study; exception: Baxter Study No. 160601\n* Severe dermatitis that would preclude adequate sites for safe product administration"}, 'identificationModule': {'nctId': 'NCT00814320', 'briefTitle': 'Gammagard Liquid and rHuPH20 in PID', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases', 'orgStudyIdInfo': {'id': '160603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Efficacy and tolerability of subcutaneous (SC) infusions of immune globulin intravenous (IGIV), 10% with hyaluronidase (rHuPH20) after ramp-up', 'interventionNames': ['Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Pharmacokinetics of intravenous (IV) infusions of immune globulin intravenous (IGIV), 10% and efficacy and tolerability of subcutaneous (SC) infusions of immune globulin intravenous (IGIV), 10% with hyaluronidase (rHuPH20) after ramp-up', 'interventionNames': ['Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)']}], 'interventions': [{'name': 'Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)', 'type': 'BIOLOGICAL', 'otherNames': ['HYQVIA'], 'description': 'Comprises subjects previously participating in Study 160601, who now only complete Study Epoch 2 (subcutaneous \\[SC\\] infusions) as bioavailability/exposure for intravenous (IV) treatment was already obtained in Study 160601.\n\nStudy Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up).', 'armGroupLabels': ['1']}, {'name': 'Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)', 'type': 'BIOLOGICAL', 'description': 'Comprises all other subjects.\n\nStudy Epoch 1: IV infusion of IGIV, 10% (same dose and frequency as pre-study) to determine pharmacokinetics.\n\nStudy Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up).', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cypress', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}, {'city': 'Irvine', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'city': 'North Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.81756, 'lon': -80.08199}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Hinsdale', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shire'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxalta now part of Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}