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 @ 2:59 PM
Ignite Modification Date: 2025-12-25 @ 1:23 PM
NCT ID: NCT01214759
Description: All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
Frequency Threshold: 0
Time Frame: Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months.
Study: NCT01214759
Study Brief: Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Truvada and Raltegravir Single arm Truvada: Tenofovir 200mg/emtricitabine 300mg once a day Raltegravir: Raltegravir 400mg twice a day None None 0 85 8 85 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing SYSTEMATIC_ASSESSMENT General disorders None View
Loose stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Delayed menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders None View
Nightmares SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Face pain SYSTEMATIC_ASSESSMENT General disorders None View