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 @ 11:00 PM
Ignite Modification Date: 2025-12-25 @ 8:29 PM
NCT ID: NCT00490269
Description: If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
Frequency Threshold: 5
Time Frame: Adverse events were collected starting on Day 0 through Day 12
Study: NCT00490269
Study Brief: Ph1 Marinol Interaction Study - Part 2 - 1
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. None None 0 6 1 6 View
Dronabinol Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. None None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anxiety Disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Catheter site hemmorage SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Catheter site adema SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Injection site inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Transamenase Increase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10.0) View
Decrease in Appetite (NOS) NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Insomnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Anxiety disorders and symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Polymenorrhea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.0) View
Lip ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View