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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:28 PM
NCT ID: NCT00470093
Description: Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Frequency Threshold: 0
Time Frame: Up to 5 months
Study: NCT00470093
Study Brief: Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Interleukin-6 and Interferon-α Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day. recombinant interferon-α recombinant interleukin-6 0 None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cold-like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Diaphoresis SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Excessive sleepiness SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Weight loss SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Xerostomia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Memory loss SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pain - neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Voice changes SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Salt sensitivity SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (3.0) View
Insomnia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Depression SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View