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 @ 6:44 PM
Ignite Modification Date: 2025-12-25 @ 4:15 PM
NCT ID: NCT02270957
Description: None
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT02270957
Study Brief: Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Abatacept Patients receive Abatacept 125 mg subcutaneously weekly for six months. 0 None 6 31 29 31 View
Placebo Patients receive Placebo subcutaneously weekly for six months. 0 None 4 35 35 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
viral syndrome NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
sickle cell crisis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
cholecystitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
cardiac valve dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
opiate overdose NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA (10.0) View
respiratory compromise NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Acute renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.0) View
blocked ureter NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
oral candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
otitis media NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (10.0) View
upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
vaginal yeast infestation NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
injection site reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View