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 @ 11:20 PM
Ignite Modification Date: 2025-12-25 @ 9:02 PM
NCT ID: NCT02121756
Description: None
Frequency Threshold: 0
Time Frame: Baseline to Week 24
Study: NCT02121756
Study Brief: Dipyridamole for Immune Activation in HIV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24 ARM A: Summary of Adverse Events for all participants randomized to receive Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24 0 None 0 21 20 21 View
ARM B: Placebo for 12 Weeks From Baseline to Week 12 ARM B: Summary of Adverse Events for all participants randomized to receive Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 0 None 0 19 14 19 View
ARM B: Dipyridamole for 12 Weeks From Week 12 to Week 24 ARM B: Summary of Adverse Events for all participants randomized to receive Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24 0 None 0 19 12 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders DAIDS View
Neurologic SYSTEMATIC_ASSESSMENT Nervous system disorders DAIDS View
musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders DAIDS View
cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders DAIDS View
respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders DAIDS View
endocrine/metabolic SYSTEMATIC_ASSESSMENT Endocrine disorders DAIDS View
chemistries SYSTEMATIC_ASSESSMENT Investigations DAIDS View
systemic SYSTEMATIC_ASSESSMENT General disorders DAIDS View
genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders DAIDS View
dermatologic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders DAIDS View
hematologic SYSTEMATIC_ASSESSMENT Investigations DAIDS View
infection SYSTEMATIC_ASSESSMENT Infections and infestations DAIDS View
ocular/visual SYSTEMATIC_ASSESSMENT Eye disorders DAIDS View
psychological/emotional SYSTEMATIC_ASSESSMENT Psychiatric disorders DAIDS View