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 @ 11:55 PM
Ignite Modification Date: 2025-12-25 @ 9:51 PM
NCT ID: NCT05215951
Description: The study was terminated, statistical analyses were not performed.
Frequency Threshold: 0
Time Frame: From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
Study: NCT05215951
Study Brief: Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Osimertinib Plus Standard Chemotherapy Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration 1 None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Head discomfort NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Malnutrition NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain of skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sleep disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Supraventricular extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View