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 @ 1:11 AM
Ignite Modification Date: 2025-12-25 @ 11:22 PM
NCT ID: NCT01147393
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01147393
Study Brief: Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular 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
Dose Level 1 veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 15 mCi/m2 None None 0 3 3 3 View
Dose Level -1 veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 10 mCi/m2 None None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia 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
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hives (infusion reaction) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Flutters (neck and throat) SYSTEMATIC_ASSESSMENT General disorders None View
Taste alteration SYSTEMATIC_ASSESSMENT General disorders None View
Easy bruisability SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bleeding gums SYSTEMATIC_ASSESSMENT General disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT General disorders None View
Hyperpigmentation (tongue) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Visual changes (aura) SYSTEMATIC_ASSESSMENT General disorders None View
Edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain (groin) SYSTEMATIC_ASSESSMENT General disorders None View
Cyst (outer labia) SYSTEMATIC_ASSESSMENT General disorders None View
Pruritic rash (left shoulder,chest) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Pain (left unla, radial head fracture) SYSTEMATIC_ASSESSMENT General disorders None View
Ear congestion SYSTEMATIC_ASSESSMENT General disorders None View
Heartburn SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Diplopia SYSTEMATIC_ASSESSMENT General disorders None View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain (joint) SYSTEMATIC_ASSESSMENT General disorders None View
Neuropathy (numbness, tingling) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Heat intolerance SYSTEMATIC_ASSESSMENT General disorders None View
Cold intolerance SYSTEMATIC_ASSESSMENT General disorders None View
Joint function (stiffness) SYSTEMATIC_ASSESSMENT General disorders None View
Orthopnea SYSTEMATIC_ASSESSMENT General disorders None View
Hyperpigmentation (hands, fingers) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritic rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Muscle weakness (leg) SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT General disorders None View