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 @ 4:49 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT02096718
Description: The residual effect period (REP) for afatinib in subjects with renal impairment (that is, the time period in which measurable drug levels were still likely to be present) was 17 days. Therefore, all AEs reported within 17 days of afatinib administration were to be considered as occurring on treatment.
Frequency Threshold: 5
Time Frame: From first administration of trial medication until the end of trial examination, up to 17 days
Study: NCT02096718
Study Brief: Afatinib in Subjects With Kidney Dysfunction
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 in Healthy Subjects Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects None None 0 14 4 14 View
Afatinib in Moderate Renal Impairment Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water None None 0 8 2 8 View
Afatinib in Severe Renal Impairment Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water None None 0 8 0 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.1 View