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 @ 4:36 AM
Ignite Modification Date: 2025-12-26 @ 3:38 AM
NCT ID: NCT01000818
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01000818
Study Brief: A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prestudy None None None 1 18 0 18 View
400 mg Raltegravir Period 1 - 400 mg Raltegravir None None 0 18 2 18 View
20 mg Famotidine + 400 mg Raltegravir Period 2 - 20 mg Famotidine + 400 mg Raltegravir None None 0 18 1 18 View
20 mg Omeprazole + 400 mg Raltegravir Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days None None 0 18 6 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ruptured coronary artery plaque NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abnormal feces NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Knee pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View