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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:36 PM
NCT ID: NCT00453193
Description: None
Frequency Threshold: 5
Time Frame: 5 years 2 months
Study: NCT00453193
Study Brief: Alemtuzumab and Pentostatin In T-cell Neoplasms
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alemtuzumab + Pentostatin Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks None None 15 24 23 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
non neutropenic fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Epididymitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
elevated asparatate aminotransferase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutropenic Fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Subdural Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
increased liver function SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
viral infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hives SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
fatugue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hepatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Ocular SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
tumor lysis syndrome SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View