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 @ 5:05 AM
Ignite Modification Date: 2025-12-26 @ 4:08 AM
NCT ID: NCT01966718
Description: None
Frequency Threshold: 0
Time Frame: Collected at each visit (two to six week intervals) up to week 16
Study: NCT01966718
Study Brief: Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Repository Corticotropin Injection Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances None None 1 8 6 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fibromyalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Reaction at injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Development of allergies SYSTEMATIC_ASSESSMENT Immune system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View