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 @ 1:03 AM
Ignite Modification Date: 2025-12-25 @ 11:16 PM
NCT ID: NCT01841593
Description: None
Frequency Threshold: 0
Time Frame: Event data collected from time of signing informed consent at screen, until discharge from study (14 days after completion).
Study: NCT01841593
Study Brief: A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD None None 1 12 6 12 View
Group B DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID None None 0 7 3 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
gingivitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pruritic rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pedal oedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
insect bite SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
light-headed SYSTEMATIC_ASSESSMENT Nervous system disorders None View