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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:44 PM
NCT ID: NCT03729869
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Study: NCT03729869
Study Brief: Impact of Progesterone on Stress Reactivity and Cannabis Use
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Progesterone Males 39 men will take 400 mg of progesterone a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Progesterone: 200 mg of exogenous progesterone twice a day 0 None 0 39 26 39 View
Placebo Males 41 men will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Placebo: One dose of matched placebo twice a day. 0 None 0 41 28 41 View
Progesterone Female 34 women will take 200 mg of progesterone twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Progesterone: 200 mg of exogenous progesterone twice a day 0 None 0 35 24 35 View
Placebo Females 31 women will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Placebo: One dose of matched placebo twice a day. 0 None 0 31 23 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Marijuana withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Viral Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vivid Dreams/Nightmares SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Stomachache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mood swings SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Night Sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sleepiness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vaginal bleeding/spotting SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Abdominal cramps/discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Emotional lability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View