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: 2025-12-24 @ 11:41 PM
Ignite Modification Date: 2025-12-25 @ 9:32 PM
NCT ID: NCT01569451
Description: Out to the last observation for each patient within 24 months (2 years) of follow up. Exposure time varied by patient. See exposure time outcome (post hoc).
Frequency Threshold: 0
Time Frame: Within 24 months (2 years) of follow up. Exposure time varied by patient.
Study: NCT01569451
Study Brief: Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Glatiramer Acetate Therapy (GA) Subjects will receive an intravenous (IV) infusion of placebo (normal saline) on study days 1 (baseline visit) and 15 according to the infusion protocol. On study day 28, all subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily. Glatiramer Acetate: 20 mg injected subcutaneously daily None None 3 27 27 27 View
Rituximab + Glatiramer Acetate Therapy (R-GA) Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily. Rituximab: intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15 Glatiramer Acetate: 20 mg injected subcutaneously daily None None 3 28 27 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders FDA guidlines View
GI related NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders FDA guidlines View
Relapse related NON_SYSTEMATIC_ASSESSMENT Immune system disorders FDA guidlines View
Neurological Condition NON_SYSTEMATIC_ASSESSMENT Nervous system disorders FDA guidlines View
Other NON_SYSTEMATIC_ASSESSMENT General disorders FDA guidlines View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
UTI NON_SYSTEMATIC_ASSESSMENT Infections and infestations FDA guidlines View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders FDA guidlines View
Backpain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders FDA guidlines View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders FDA guidlines View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders FDA guidlines View
Injection-site reaction NON_SYSTEMATIC_ASSESSMENT General disorders FDA guidlines View
URI NON_SYSTEMATIC_ASSESSMENT Infections and infestations FDA guidlines View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations FDA guidlines View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders FDA guidlines View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders FDA guidlines View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders FDA guidlines View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders FDA guidlines View
Infusion-related reaction NON_SYSTEMATIC_ASSESSMENT General disorders FDA guidlines View
Gastrointestinal Issues NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders FDA guidlines View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders FDA guidlines View