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 @ 9:22 PM
Ignite Modification Date: 2025-12-25 @ 7:08 PM
NCT ID: NCT02667704
Description: None
Frequency Threshold: 5
Time Frame: From first drug administration until 13 days after the last drug administration, up to 21 days
Study: NCT02667704
Study Brief: Influence of Bosentan on the Pharmacokinetics of Nintedanib
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 (R) Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 administered orally with 240 millilitre (mL) of water. None None 0 13 4 13 View
Bosentan Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 6 of period 2 administered orally with 240 mL of water None None 0 13 4 13 View
Bosentan+Nintedanib (T) Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 7 and 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water None None 0 13 2 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View