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 @ 7:34 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT01427803
Description: AEs were collected at the Follow-up telephone interview after completion of the 28 day Use Phase or sooner if they discontinued from the study. The safety population consisted of all participants who took product. Safety data from the two cohorts were pooled in one group as both cohorts received the same treatment.
Frequency Threshold: 1
Time Frame: 28 days
Study: NCT01427803
Study Brief: Actual Use Trial of Naproxen Sodium
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Naproxen Sodium ER (BAYH6689) Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever. None None 6 745 89 745 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.1) View
cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.1) View
diarrhea haemorrhagic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
gallbladder disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (11.1) View
hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (11.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.1) View