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 @ 12:10 PM
Ignite Modification Date: 2025-12-25 @ 11:59 AM
NCT ID: NCT00755261
Description: None
Frequency Threshold: 5
Time Frame: none, study was terminated early because of low accrual.
Study: NCT00755261
Study Brief: Phase II Study of Doxorubicin and Avastin® in Sarcoma.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Avastin and Doxorubicin Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance. Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes. Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter. None None 2 4 1 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
acute renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
dysphagia -unable to swallow medications SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View