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 @ 5:12 AM
Ignite Modification Date: 2025-12-26 @ 4:17 AM
NCT ID: NCT01928927
Description: Protocol definition of Other (Not Including Serious) Adverse Events: 1) signs and symptoms Grade ≥2 and any that led to a change in treatment regardless of grade; 2) all new diagnoses; 3) Grade ≥2 lab values. All lab toxicities that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. The following labs regardless of grade: creatinine, AST, ALT, hemoglobin, platelet count, fasting lipids and fasting glucose. DAIDS AE Grading Table (V1.0) was used.
Frequency Threshold: 5
Time Frame: From baseline to Week 48.
Study: NCT01928927
Study Brief: Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A: Telmisartan Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan 0 None 3 29 24 29 View
Arm B: No Study Drug Participants received no study drug and will follow week 0-48 evaluation schedule. Control 0 None 1 15 10 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Herpes zoster disseminated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Perianal erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Rectal discharge SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.1 View
Gastroenteritis shigella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Penile discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Penile pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Anorectal swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View