Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:08 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT01650350
Description: None
Frequency Threshold: 0
Time Frame: Monthly and 30 days post last dose of drug (approximately 9 months)
Study: NCT01650350
Study Brief: Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Dose Naltrexone LDN, 5 mg/day-(1 cycle = 28 days). Naltrexone None None 0 7 7 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
RBC SYSTEMATIC_ASSESSMENT Investigations None View
infection SYSTEMATIC_ASSESSMENT Investigations None View
abd pain SYSTEMATIC_ASSESSMENT Investigations None View
kidney pain SYSTEMATIC_ASSESSMENT Investigations None View
fatigue SYSTEMATIC_ASSESSMENT Investigations None View
anorexia SYSTEMATIC_ASSESSMENT Investigations None View
nausea SYSTEMATIC_ASSESSMENT Investigations None View
upset stomach SYSTEMATIC_ASSESSMENT Investigations None View
diarrhea SYSTEMATIC_ASSESSMENT Investigations None View
leg cyst SYSTEMATIC_ASSESSMENT Investigations None View
LFT SYSTEMATIC_ASSESSMENT Investigations None View
seg neutrophils SYSTEMATIC_ASSESSMENT Investigations None View
constipation SYSTEMATIC_ASSESSMENT Investigations None View
dyspnea SYSTEMATIC_ASSESSMENT Investigations None View
achilles pain SYSTEMATIC_ASSESSMENT Investigations None View
pain scalp SYSTEMATIC_ASSESSMENT Investigations None View
scalp lesion- Moh's SYSTEMATIC_ASSESSMENT Investigations None View
weight loss SYSTEMATIC_ASSESSMENT Investigations None View
PLT SYSTEMATIC_ASSESSMENT Investigations None View
Rash- thigh SYSTEMATIC_ASSESSMENT Investigations None View
creatinine SYSTEMATIC_ASSESSMENT Investigations None View
edema SYSTEMATIC_ASSESSMENT Investigations None View
Pain- shoulder SYSTEMATIC_ASSESSMENT Investigations None View
pain-hip SYSTEMATIC_ASSESSMENT Investigations None View
insomnia SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Investigations None View