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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:50 PM
NCT ID: NCT01215851
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01215851
Study Brief: Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TMC207 TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide placebo None None 0 15 7 15 View
TMC207 and Pyrazinamide TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide (dosed by weight) None None 0 15 6 15 View
PA-824 and Pyrazinamide PA-824 200mg and pyrazinamide (dosed by weight)and moxifloxacin placebo None None 0 15 7 15 View
PA-824 and Moxifloxacin and Pyrazinamide PA-824 200 mg and pyrazinamide (dosed by weight) and moxifloxacin 400 mg None None 1 15 8 15 View
Rifafour e-275 mg Rifafour e-275 275 mg None None 0 10 5 10 View
TMC207 and PA-824 TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 200 mg None None 1 15 9 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening of Pulmonary Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations Medra 13.1 View
Neurocysticercosis SYSTEMATIC_ASSESSMENT Infections and infestations Medra 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 13.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 13.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 13.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 13.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 13.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 13.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 13.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations Medra 13.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations Medra 13.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations Medra 13.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations Medra 13.1 View
Blood amylase increased SYSTEMATIC_ASSESSMENT Investigations Medra 13.1 View
electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations Medra 13.1 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations Medra 13.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations Medra 13.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations Medra 13.1 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations Medra 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 13.1 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 13.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 13.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 13.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 13.1 View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 13.1 View
Conjunctival hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders Medra 13.1 View
Eyelid edema SYSTEMATIC_ASSESSMENT Eye disorders Medra 13.1 View
Lenticular opacities SYSTEMATIC_ASSESSMENT Eye disorders Medra 13.1 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Medra 13.1 View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Medra 13.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Medra 13.1 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders Medra 13.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra 13.1 View
Type I diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Medra 13.1 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Medra 13.1 View