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 @ 2:41 AM
Ignite Modification Date: 2025-12-26 @ 1:20 AM
NCT ID: NCT00564733
Description: Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of signing the informed consent through 30 days after the final dose of chemotherapy, up to 24 weeks.
Study: NCT00564733
Study Brief: FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chemotherapy Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2. carboplatin: Given IV docetaxel: Given IV gemcitabine hydrochloride: Given IV paclitaxel: Given IV computed tomography: Undergo FDG PET/CT positron emission tomography: Undergo FDG PET/CT fludeoxyglucose F 18: Given IV imaging biomarker analysis: Correlative studies None None 3 46 20 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTC 3.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTC 3.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations CTC 3.0 View
acute renal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC 3.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC 3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased ALT SYSTEMATIC_ASSESSMENT Investigations CTC 3.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC 3.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC 3.0 View
Thromboembolic Event SYSTEMATIC_ASSESSMENT Vascular disorders CTC 3.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC 3.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC 3.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTC 3.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTC 3.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC 3.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC 3.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC 3.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTC 3.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC 3.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTC 3.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC 3.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC 3.0 View
Pain- NOS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC 3.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC 3.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTC 3.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTC 3.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTC 3.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations CTC 3.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC 3.0 View