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 @ 5:17 PM
Ignite Modification Date: 2025-12-25 @ 2:54 PM
NCT ID: NCT00763750
Description: None
Frequency Threshold: 5
Time Frame: Time of signing consent to 30 days post last dose of drug (approximately 4 months)
Study: NCT00763750
Study Brief: PPX, Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PPX +TMZ+XRT XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36 PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays) None None 6 25 25 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PLT gr 4, ANC 4, HGB 3 F/U: ANC to gr3, HGB and PLT to gr 2 SYSTEMATIC_ASSESSMENT Investigations None View
gr 4 PLT, ANC 3, HGB2 & FU: death SYSTEMATIC_ASSESSMENT Investigations None View
Plt gr4, ANC4, weakness/failure to thrive gr 3 & FU:gr 4 Leuko, gr 3 HGB, Anorexia gr 3, death SYSTEMATIC_ASSESSMENT Investigations None View
weakness (gr 3) SYSTEMATIC_ASSESSMENT Investigations None View
seizure - no grade SYSTEMATIC_ASSESSMENT Investigations None View
gr 3 dehydration, gr 3 weakness, gr 3 Anorexia SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
rash SYSTEMATIC_ASSESSMENT Investigations None View
infection normal ANC (thrush included) SYSTEMATIC_ASSESSMENT Investigations None View
seizure SYSTEMATIC_ASSESSMENT Investigations None View
headache SYSTEMATIC_ASSESSMENT Investigations None View
insomnia SYSTEMATIC_ASSESSMENT Investigations None View
vomiting SYSTEMATIC_ASSESSMENT Investigations None View
Nausea SYSTEMATIC_ASSESSMENT Investigations None View
Alopecia SYSTEMATIC_ASSESSMENT Investigations None View
Glucose SYSTEMATIC_ASSESSMENT Investigations None View
Albumin SYSTEMATIC_ASSESSMENT Investigations None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
PLT SYSTEMATIC_ASSESSMENT Investigations None View
ANC SYSTEMATIC_ASSESSMENT Investigations None View
WBC SYSTEMATIC_ASSESSMENT Investigations None View
HGB SYSTEMATIC_ASSESSMENT Investigations None View
fatigue SYSTEMATIC_ASSESSMENT Investigations None View
constipation SYSTEMATIC_ASSESSMENT Investigations None View