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 @ 12:32 AM
Ignite Modification Date: 2025-12-25 @ 10:40 PM
NCT ID: NCT01536067
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01536067
Study Brief: Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Monoclonal Antibody Therapy) INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. ofatumumab: Given IV bortezomib: Given SC laboratory biomarker analysis: Correlative studies None None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Iritis SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Infusion site rash SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site joint redness SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tumour flare SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensory loss SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Scrotal swelling SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View