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: 2025-12-24 @ 9:08 PM
Ignite Modification Date: 2025-12-25 @ 6:59 PM
NCT ID: NCT00830804
Description: Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Frequency Threshold: 5
Time Frame: From start of study treatment to week 52
Study: NCT00830804
Study Brief: Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks None None 13 112 78 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Jejunal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Henoch-Schonlein purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Alcohol poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Substance abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood glucose abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Low density lipoprotein abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Blood cholesterol SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View