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 @ 9:14 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT01181804
Description: In this study, participants received two single doses of boceprevir 800 mg, once as capsules and once as tablets, under fed and fasted conditions, in a crossover manner; adverse events were pooled as tablets (fed condition), capsules (fed condition), tablets (fasted condition), or capsules (fasted condition).
Frequency Threshold: 5
Time Frame: None
Study: NCT01181804
Study Brief: Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Boceprevir Capsules (Fasted) In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions. None None 0 117 5 117 View
Boceprevir Tablets (Fed) In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions. None None 0 60 13 60 View
Boceprevir Capsules (Fed) In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions. None None 0 60 6 60 View
Boceprevir Tablets (Fasted) In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions. None None 0 117 7 117 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Menstruation irregular SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (13.1) View