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: 2025-12-24 @ 5:54 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT00984568
Description: None
Frequency Threshold: 5
Time Frame: Up to Week 50
Study: NCT00984568
Study Brief: Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Top-Hold Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day. None None 2 15 14 15 View
Step-Up Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter. None None 1 13 11 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastroenteritis Astroviral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gastroenteritis Norovirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Giardiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Helicobacter Gastritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Herpes Simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Scarlet Fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Colitis Ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastritis Erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Periodontitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Reflux Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 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
Joint Swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Muskuloskeletal Discomfort 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
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Intercostal Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Sensory Loss SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Iron Deficiency Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.0 View
Alveolitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Cushing's Syndrome SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Coombs Test Positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Aortic Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Borrelia Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Clostridial Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gastrointestinal Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View