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 @ 4:23 AM
Ignite Modification Date: 2025-12-26 @ 3:25 AM
NCT ID: NCT01483820
Description: None
Frequency Threshold: 5
Time Frame: From date of first dose of TPI 287 until 30 days past last dose. Related AE's collected until resolution.
Study: NCT01483820
Study Brief: Safety and Efficacy Study of TPI-287 in Neuroblastoma and Medulloblastoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TPI 287 Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle. None None 2 8 6 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Progression of Disease resulting in Death NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
alanine aminotransferase (ALT) increase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Aspartate aminotransferase (AST) increase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (4.0) View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Lymphocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Nervous system disorders NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View