{"description":"As per design, participants randomized to PBO either switched to CZP 200mg Q2W or escaped to CZP 400mg Q2W at Week 16, leading to a significantly lower exposure in PBO arm than in CZP arm. Considering the limitations of such comparison, AEs reported while the participants were on PBO are not included in this summary.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":170,"description":"This arm consisted of all participants who received CZP 200 mg at any time during the study.","id":"EG000","otherNumAffected":76,"otherNumAtRisk":170,"seriousNumAffected":24,"seriousNumAtRisk":170,"title":"CZP 200 mg Q2W (TCS)"},{"deathsNumAffected":1,"deathsNumAtRisk":149,"description":"This arm consisted of all participants who received CZP 400 mg at any time during the study.","id":"EG001","otherNumAffected":75,"otherNumAtRisk":149,"seriousNumAffected":12,"seriousNumAtRisk":149,"title":"CZP 400 mg Q2W (TCS)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":170,"numEvents":55},{"groupId":"EG001","numAffected":35,"numAtRisk":149,"numEvents":45}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":170,"numEvents":20},{"groupId":"EG001","numAffected":18,"numAtRisk":149,"numEvents":21}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":170,"numEvents":15},{"groupId":"EG001","numAffected":4,"numAtRisk":149,"numEvents":4}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":170,"numEvents":12},{"groupId":"EG001","numAffected":4,"numAtRisk":149,"numEvents":4}],"term":"Pharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":170,"numEvents":15},{"groupId":"EG001","numAffected":10,"numAtRisk":149,"numEvents":14}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":170,"numEvents":8},{"groupId":"EG001","numAffected":5,"numAtRisk":149,"numEvents":5}],"term":"Ligament sprain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":170,"numEvents":6},{"groupId":"EG001","numAffected":8,"numAtRisk":149,"numEvents":8}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":170,"numEvents":10},{"groupId":"EG001","numAffected":6,"numAtRisk":149,"numEvents":6}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":170,"numEvents":3},{"groupId":"EG001","numAffected":8,"numAtRisk":149,"numEvents":8}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":170,"numEvents":10},{"groupId":"EG001","numAffected":12,"numAtRisk":149,"numEvents":19}],"term":"Psoriasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":170,"numEvents":8},{"groupId":"EG001","numAffected":9,"numAtRisk":149,"numEvents":9}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Cardiac failure congestive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":2}],"term":"Tolosa-Hunt syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Haemorrhagic necrotic pancreatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Pharyngo-oesophageal diverticulum"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Rectal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Hepatic failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":170,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Drug-induced liver injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Anaphylactic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Abdominal abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Appendicitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Bartholin's abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Ovarian abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Varicella"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Infected bite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Pneumonia legionella"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Chronic sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Haematoma infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Contusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Blood count abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Transaminases increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Chest X-ray abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Rotator cuff syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":170,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Psoriatic arthropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Benign salivary gland neoplasm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Non-small cell lung cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Prostate cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Basal cell carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Migraine"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Multiple sclerosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":170,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Transient ischaemic attack"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Pregnancy with contraceptive device"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Menorrhagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Penile swelling"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Genital haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Scrotal swelling"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Laryngeal cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Atelectasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Tonsillar cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":149,"numEvents":1}],"term":"Skin ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":149,"numEvents":0}],"term":"Distributive shock"}],"timeFrame":"Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152)."}