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: 2025-12-26 @ 4:04 PM
Ignite Modification Date: 2025-12-26 @ 4:04 PM
NCT ID: NCT02161406
Description: Coding of adverse events into body system was performed by the study chair for adverse events and by the medical monitors for serious adverse events.
Frequency Threshold: 5
Time Frame: 52 weeks
Study: NCT02161406
Study Brief: A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
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 125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks 2 None 9 44 35 44 View
Placebo 125mg Placebo Placebo: 125 mg of Placebo 1 None 12 44 40 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis of right elbow SYSTEMATIC_ASSESSMENT Infections and infestations None View
Healthcare associated pneumonia (HCAP) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Left side mastoiditis/ abrythnitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Digital Ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
NSTEMI Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Arterial Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Arterial Hypertension and Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Worsening AV block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia due to GI dysmotility SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia from myositis and prolonged hospitalization SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Erosive esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GAVE; Severe anemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pseudo obstruction of the small bowel, paralytic ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GAVE SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Depression with Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Basal cell carcinoma (BCC) SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous Cell Carcinoma In-situ Left Anterior Ear SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal crisis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT General disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Non-serious Adverse Events SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting (Emesis) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT General disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pruritis (Itching) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View