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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT01410058
Description: All participants were monitored for adverse events throughout the study. The study medical officer documented any adverse events observed from clinical examinations or self-reported by the participants at each of the two visits. Urinalysis and Serum biochemistries were determined and graded based on CTCAE.
Frequency Threshold: 0
Time Frame: Adverse event data was collected at baseline (day 22) and at final visit (day 35).
Study: NCT01410058
Study Brief: Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Efavirenz HIV positive patients on efavirenz containing regimen, taking Moringa oleifera Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules 0 None 0 6 4 6 View
Nevirapine HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules 0 None 0 13 4 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated liver transaminase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Altered creatinine clearance SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View