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 @ 10:41 PM
Ignite Modification Date: 2025-12-25 @ 8:12 PM
NCT ID: NCT04552535
Description: Adverse events (AEs) were only collected and reported for 2L afatinib treatment group according to protocol requirements. All 2L afatinib treatment group patients (pts) who initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy and had started second-line (2L) treatment with afatinib at least 3 months prior to date of data collection. Serious AEs were not collected and reported for this study.
Frequency Threshold: 5
Time Frame: From the start of second-line treatment to the end of follow-up, up to 15 months.
Study: NCT04552535
Study Brief: A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Second-line Afatinib Treatment Group Patients in the second-line afatinib treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with afatinib at least 3 months prior to the date of data collection. 2 None 0 0 37 99 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 23.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 23.1 View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 23.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA version 23.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 23.1 View