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 @ 5:01 AM
Ignite Modification Date: 2025-12-26 @ 4:02 AM
NCT ID: NCT03095118
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
Study: NCT03095118
Study Brief: Daratumumab in Treatment of PGNMID and C3 GN
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Daratumumab Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses 0 None 3 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Eye Chemosis SYSTEMATIC_ASSESSMENT Eye disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
C. difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
UTI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
URI SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Throat Irritation SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tingling in feet SYSTEMATIC_ASSESSMENT General disorders None View
Flushed SYSTEMATIC_ASSESSMENT General disorders None View
Watery eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Itching SYSTEMATIC_ASSESSMENT General disorders None View
Sneezing SYSTEMATIC_ASSESSMENT General disorders None View
Chest tightness SYSTEMATIC_ASSESSMENT General disorders None View
Vagal response SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lip tingling SYSTEMATIC_ASSESSMENT General disorders None View
Skin itchy at IV site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hoarse voice SYSTEMATIC_ASSESSMENT General disorders None View
Sensation of facial swelling SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Night sweats SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
Leg cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sore scalp SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Restless legs SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sore in mouth SYSTEMATIC_ASSESSMENT General disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Foot pain SYSTEMATIC_ASSESSMENT General disorders None View
Low back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View