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 @ 10:09 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT04783935
Description: None
Frequency Threshold: 5
Time Frame: From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years)
Study: NCT04783935
Study Brief: Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cladribine Participants received oral Cladribine (tradename Mavenclad®) over 2 years, administered as 1 treatment course of 1.75 mg/kg body weight per year in MAGNIFY MS parent study. The treatment course consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight. 0 None 13 219 79 219 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure acute NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Peritonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Plasma cell myeloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Multiple sclerosis relapse NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Malignant gastrointestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Peritonitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Malignant melanoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Nodular melanoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Prostatic adenoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Thyroid neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Abortion missed NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 26.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View