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 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 11:38 PM
NCT ID: NCT01119794
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01119794
Study Brief: Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ofatumumab IV, Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22, Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression None None 1 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Investigations None View
vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
infusion reaction SYSTEMATIC_ASSESSMENT Investigations None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
glucose SYSTEMATIC_ASSESSMENT Investigations None View
abdominal pain SYSTEMATIC_ASSESSMENT Investigations None View
nausea SYSTEMATIC_ASSESSMENT Investigations None View
shortness of breath SYSTEMATIC_ASSESSMENT Investigations None View
edema SYSTEMATIC_ASSESSMENT Investigations None View
fatigue SYSTEMATIC_ASSESSMENT Investigations None View
white blood cell decrease SYSTEMATIC_ASSESSMENT Investigations None View
general pain SYSTEMATIC_ASSESSMENT General disorders None View
rash SYSTEMATIC_ASSESSMENT Investigations None View
derm skin other SYSTEMATIC_ASSESSMENT Investigations None View
anemia SYSTEMATIC_ASSESSMENT Investigations None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
neuropathy SYSTEMATIC_ASSESSMENT Investigations None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
neutropenia SYSTEMATIC_ASSESSMENT Investigations None View
Red blodd cell SYSTEMATIC_ASSESSMENT Investigations None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
Liver function test abnormalities SYSTEMATIC_ASSESSMENT Investigations None View
muscle aches SYSTEMATIC_ASSESSMENT General disorders None View
phosphorus SYSTEMATIC_ASSESSMENT Investigations None View
sweating SYSTEMATIC_ASSESSMENT Investigations None View
mood alteration SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
phlebitis SYSTEMATIC_ASSESSMENT Investigations None View
creatinine SYSTEMATIC_ASSESSMENT Investigations None View
dehydration SYSTEMATIC_ASSESSMENT Investigations None View
hip pain SYSTEMATIC_ASSESSMENT Investigations None View
cough SYSTEMATIC_ASSESSMENT Investigations None View
back pain SYSTEMATIC_ASSESSMENT Investigations None View
heartburn SYSTEMATIC_ASSESSMENT Investigations None View
upper respiratory infection SYSTEMATIC_ASSESSMENT Investigations None View