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 @ 3:46 AM
Ignite Modification Date: 2025-12-26 @ 2:32 AM
NCT ID: NCT04098302
Description: Participants provided subjective reports of adverse events at each bi-weekly study visit using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview, a widely used tool for systematic assessment of adverse events.
Frequency Threshold: 5
Time Frame: Phase 1 first 12 weeks: dutasteride vs. placebo arms data collected at bi-weekly visits (week 2 to week 12) Phase 2 second 12 weeks for phase 1 participants with <60% reduction drinks per week transition to either dutasteride or naltrexone: placebo-dutasteride vs. dutasteride-naltrexone arms data collected at bi-weekly Phase 2 visits (week 14 to week 24)
Study: NCT04098302
Study Brief: Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dutasteride two 0.5 mg capsules of dutasteride daily for 12 weeks 0 None 0 75 46 75 View
Placebo Capsule inactive placebo matched in appearance with dutasteride capsules for 12 weeks 0 None 0 80 41 80 View
Dutasteride - Naltrexone Phase 1 (week 1-12) dutasteride arm participants with \<60% reduction in drinks per week assigned to naltrexone 50 mg daily for Phase 2 (weeks 13-24) 0 None 0 49 34 49 View
Placebo - Dutasteride Phase 1 (week 1-12) placebo arm participants with \<60% reduction in drinks per week assigned to dutasteride 1mg daily for Phase 2 (weeks 13-24) 0 None 2 59 33 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fall from step ladder SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizzy or lightheaded SYSTEMATIC_ASSESSMENT General disorders None View
Numbness or Tingling around Mouth, Fingers, or Toes SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Decreased libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle or body ache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Difficulty sleeping SYSTEMATIC_ASSESSMENT Nervous system disorders None View