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 @ 3:31 PM
Ignite Modification Date: 2025-12-25 @ 1:45 PM
NCT ID: NCT01770392
Description: None
Frequency Threshold: 5
Time Frame: From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
Study: NCT01770392
Study Brief: Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nintedanib 150 mg of nintedanib was given as a single dose on Day 1. None None 0 26 5 26 View
Washout Period washout period of at least 14 days between the administrations of nintedanib. During this period no trial drug was administered None None 0 26 2 26 View
Rifampicin 600 mg rifampicin was given every evening from Day -7 to Day -1 None None 0 25 25 25 View
Nintedanib + Rifampicin 600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1. None None 0 25 4 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Faeces discoloured SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.1 View