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 @ 5:02 AM
Ignite Modification Date: 2025-12-26 @ 4:03 AM
NCT ID: NCT01536418
Description: SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Frequency Threshold: 5
Time Frame: Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact.
Study: NCT01536418
Study Brief: An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With 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
GSK1605786A 500 mg, Once Daily Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks. 0 None 8 127 61 127 View
GSK1605786A 500 mg, Twice Daily Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks. 0 None 6 126 57 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Oesophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.1 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View