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 @ 5:31 PM
Ignite Modification Date: 2025-12-25 @ 3:04 PM
NCT ID: NCT02073968
Description: Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
Frequency Threshold: 0
Time Frame: Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients.
Study: NCT02073968
Study Brief: PET-Adjusted Intensity Modulated Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II-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
Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy, patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT 11 None 15 35 35 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View