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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:47 AM
NCT ID: NCT00262860
Description: None
Frequency Threshold: 5
Time Frame: days 1 and 8 of each cycle of therapy, up to 2 months
Study: NCT00262860
Study Brief: Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin's 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
Bortezomib, Gemcitabine Hydrochloride bortezomib gemcitabine hydrochloride Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule. None None 5 18 18 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytompenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
elevated transaminases SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
abdominal pain/cramps SYSTEMATIC_ASSESSMENT General disorders None View
lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
headache/migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
DVT near line SYSTEMATIC_ASSESSMENT Vascular disorders None View
worsening leg ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
elevated transaminases SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
abdominal pain/cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
pain SYSTEMATIC_ASSESSMENT General disorders None View
hypocalcemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View