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 @ 2:20 AM
Ignite Modification Date: 2025-12-26 @ 12:52 AM
NCT ID: NCT01950234
Description: None
Frequency Threshold: 0
Time Frame: 36 Months
Study: NCT01950234
Study Brief: ACTH in Progressive Forms of MS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ACTH ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month ACTH: Acthar gel 0 None 8 29 29 29 View
Placebo Placebo subcutaneous injections administered on 3 consecutive days per month Placebo: Placebo 0 None 7 30 29 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
infection SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alopecia SYSTEMATIC_ASSESSMENT General disorders None View
Bladder function SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bruising SYSTEMATIC_ASSESSMENT General disorders None View
cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
dermatologic SYSTEMATIC_ASSESSMENT General disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT General disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
genitourinary SYSTEMATIC_ASSESSMENT General disorders None View
Infection SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Metabolic SYSTEMATIC_ASSESSMENT General disorders None View
Metabolic/endocrine SYSTEMATIC_ASSESSMENT General disorders None View
Mood SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT General disorders None View
Neoplasm SYSTEMATIC_ASSESSMENT General disorders None View
Neurologic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
other SYSTEMATIC_ASSESSMENT General disorders None View
renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sleep SYSTEMATIC_ASSESSMENT General disorders None View
visual SYSTEMATIC_ASSESSMENT General disorders None View
weight gain SYSTEMATIC_ASSESSMENT General disorders None View