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 @ 9:20 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT03537404
Description: None
Frequency Threshold: 0
Time Frame: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study
Study: NCT03537404
Study Brief: A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment A (Part 1) Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days 0 None 0 18 1 18 View
Treatment B (Part 1) Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days 0 None 0 18 0 18 View
Treatment C (Part 1) Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily coadministered with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily and Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days 0 None 0 18 4 18 View
Treatment A (Part 2) Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days 0 None 0 18 0 18 View
Treatment B (Part 2) Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days 0 None 0 18 0 18 View
Treatment C (Part 2) Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily coadministered with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily and Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days 0 None 0 18 1 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedRA 19.0 View
Blood Lactate Dehydrogenase Decreased SYSTEMATIC_ASSESSMENT Investigations MedRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA 19.0 View
Gamma-Glutamyltransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedRA 19.0 View