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 @ 12:03 AM
Ignite Modification Date: 2025-12-25 @ 10:01 PM
NCT ID: NCT01426958
Description: None
Frequency Threshold: 5
Time Frame: First administration of trial medication until 28 days after last administration of trial medication
Study: NCT01426958
Study Brief: Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Afatinib + Timed Rtv Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose. None None 0 22 5 22 View
Afatinib Subjects were treated with a single dose of Afatinib 40mg on Day 1. None None 0 23 2 23 View
Afatinib + Concomittant Rtv Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose. None None 0 24 7 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View