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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:37 AM
NCT ID: NCT01656460
Description: None
Frequency Threshold: 0
Time Frame: Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Study: NCT01656460
Study Brief: Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 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
Arm 1-Stereotactic Radiation Dose Level 1 Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy None None 1 3 3 3 View
Arm 2-Stereotactic Radiation Dose Level 2 Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy None None 0 3 2 3 View
Arm 3-Stereotactic Radiation Dose Level 3 Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy None None 1 3 3 3 View
Arm 4-Stereotactic Radiation Dose Level 4 Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy None None 2 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
K(3), AKI secondary to cisplatin nephrotoxicity(5) SYSTEMATIC_ASSESSMENT Investigations None View
AKI(2*) RT poor intake, CR(2*) RT poor intake, Fatigue (2*) RT pneumonia or chemo, H/A(2*) related SYSTEMATIC_ASSESSMENT Investigations None View
hypoglycemia(2*), chest pain (3*), Hyperglycemia(3*), HGB(2*), CR(1*) k(1*) SYSTEMATIC_ASSESSMENT Investigations None View
Dyspnea 4*, Tachycardia 2*, Fever 1*cough 1*- SYSTEMATIC_ASSESSMENT Investigations None View
Bronchopulmonary Hemorrhage (5) SYSTEMATIC_ASSESSMENT Investigations None View
upper respiratory infection SYSTEMATIC_ASSESSMENT Investigations None View
URI (3*) rt chemo, PLT(2*) PR chemo, hyponatremia (3*) PR chemo, bilateral thigh pain(2*) suspected SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
pleural effusion SYSTEMATIC_ASSESSMENT Investigations None View
esophagitis SYSTEMATIC_ASSESSMENT Investigations None View
cough SYSTEMATIC_ASSESSMENT Investigations None View
Ca SYSTEMATIC_ASSESSMENT Investigations None View
ALT SYSTEMATIC_ASSESSMENT Investigations None View
diarrhea SYSTEMATIC_ASSESSMENT Investigations None View
HgB SYSTEMATIC_ASSESSMENT Investigations None View
vomiting SYSTEMATIC_ASSESSMENT Investigations None View
WBC SYSTEMATIC_ASSESSMENT Investigations None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
dermatitis SYSTEMATIC_ASSESSMENT Investigations None View
Lymph SYSTEMATIC_ASSESSMENT Investigations None View
Bili SYSTEMATIC_ASSESSMENT Investigations None View
dyspnea/hypoxia SYSTEMATIC_ASSESSMENT Investigations None View
myalgia SYSTEMATIC_ASSESSMENT Investigations None View
K SYSTEMATIC_ASSESSMENT Investigations None View
ANC SYSTEMATIC_ASSESSMENT Investigations None View
fatigue SYSTEMATIC_ASSESSMENT Investigations None View
pain- thigh/leg/groin/chest wall SYSTEMATIC_ASSESSMENT Investigations None View
nausea SYSTEMATIC_ASSESSMENT Investigations None View
pneumonitis ,upper respiratory infection (URI),lung Infection (influenza A) SYSTEMATIC_ASSESSMENT Investigations None View
AST SYSTEMATIC_ASSESSMENT Investigations None View
Magnesium SYSTEMATIC_ASSESSMENT Investigations None View
fever SYSTEMATIC_ASSESSMENT Investigations None View
chills SYSTEMATIC_ASSESSMENT Investigations None View
edema SYSTEMATIC_ASSESSMENT Investigations None View
aspiration SYSTEMATIC_ASSESSMENT Investigations None View