Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:12 AM
Ignite Modification Date: 2025-12-26 @ 12:41 AM
NCT ID: NCT00873860
Description: None
Frequency Threshold: 0
Time Frame: Day 1 to 169
Study: NCT00873860
Study Brief: Study to Evaluate the Safety and Efficacy of CAT-354
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. None None 3 47 17 47 View
CAT-354 150 mg CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. None None 2 47 19 47 View
CAT-354 300 mg CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. None None 0 51 25 51 View
CAT-354 600 mg CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. None None 1 48 25 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Post cholecystectomy syndrome SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Brain injury SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Somatoform disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Monocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Monocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Infusion site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Biliary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Biliary dyskinesia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.0 View
Acute tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
H1n1 influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pharyngitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Vulvovaginitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Muscle rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood bilirubin SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood chloride increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Reticulocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Urine analysis abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Lipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Intercostal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Acute psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Crystalluria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Leukocyturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Nitrituria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Urinary tract inflammation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Menopausal disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Menstruation irregular SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Labile hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View