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 @ 2:54 AM
Ignite Modification Date: 2025-12-26 @ 1:35 AM
NCT ID: NCT01258933
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events monitored monthly until follow-up, assessed up to 3 years. Mortality was monitored up to approximately 13 years, 3 months.
Study: NCT01258933
Study Brief: Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy
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 Ofatumumab 300 mg dose 1, then 1,000 mg weekly \* 7, (treatment) then 1,000 mg every 2 months beginning on week 12 for a total of 2 years of treatment or until progression (maintenance) of disease. The follow-up period will be the period after completion of maintenance. Ofatumumab: 300 mg Dose 1, then 1,000 mg weekly x 7, (treatment) then 1,000 mg every 2 months beginning on week 12 1 None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Splenectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (4.0) View
Infusion reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Flu-like Syndrome SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View