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 @ 4:41 AM
Ignite Modification Date: 2025-12-26 @ 3:43 AM
NCT ID: NCT00561418
Description: None
Frequency Threshold: 5
Time Frame: The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.
Study: NCT00561418
Study Brief: Vorinostat After Stem Cell Transplant in Treating Patients With High-Risk Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vorinostat (SAHA) Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations. vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles. Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.) None None 0 23 12 23 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fatigue SYSTEMATIC_ASSESSMENT Investigations CTCAE version 3.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE version 3.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE version 3.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE version 3.0 View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View