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 @ 3:18 AM
Ignite Modification Date: 2025-12-26 @ 1:56 AM
NCT ID: NCT03047005
Description: Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.
Frequency Threshold: 5
Time Frame: Month 1
Study: NCT03047005
Study Brief: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NB Medication Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication 0 None 0 32 21 32 View
Placebo Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo 0 None 0 34 18 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View