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 @ 12:13 PM
Ignite Modification Date: 2025-12-25 @ 12:01 PM
NCT ID: NCT02092961
Description: For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
Frequency Threshold: 5
Time Frame: 24 weeks
Study: NCT02092961
Study Brief: Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FOSTA 100 MG BID Dosing Group A None None 3 33 17 33 View
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period None None None 0 22 7 22 View
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period None None None 1 29 4 29 View
ADALIMUMAB 40 MG Dosing Group D None None 3 28 7 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
FEMORAL NECK FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
POST PROCEDURAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
EXOSTOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
ORTHOSTATIC HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
RHEUMATOID ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
GAMMA-GLUTAMYLTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
RASH MACULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View