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 @ 11:47 AM
Ignite Modification Date: 2025-12-26 @ 10:20 AM
NCT ID: NCT02096861
Description: End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
Frequency Threshold: 5
Time Frame: Up to End-of-Study
Study: NCT02096861
Study Brief: Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CT-P13 - CT-P13 CT-P13 followed by CT-P13 from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose 0 None 4 56 37 56 View
CT-P13 - Remicade CT-P13 followed by Remicade from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose 0 None 4 55 36 55 View
Remicade - Remicade Remicade followed by Remicade from Week 30 Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose 0 None 4 54 36 54 View
Remicade - CT-P13 Remicade followed by CT-P13 from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose 0 None 7 55 40 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abscess intestinal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peritoneal tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tuberculous pleurisy SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders None View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infusion-related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View