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 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:51 PM
NCT ID: NCT01195467
Description: From date of informed consent to date of follow up visit
Frequency Threshold: 0
Time Frame: 5 months
Study: NCT01195467
Study Brief: Atripla to Raltegravir Switch Study for CNS Toxicity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks. None None 4 40 8 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Peripheral neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thombosed haemorrhoids NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Deliberate overdose NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Groin pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bilateral Arm Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ichthyosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Night Sweats NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View