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 @ 8:00 PM
Ignite Modification Date: 2025-12-25 @ 5:34 PM
NCT ID: NCT01317004
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01317004
Study Brief: Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fingolimod Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period. None None 4 50 13 50 View
Multiple Sclerosis Disease Modifying Treatment (MS DMT) Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. None None 1 11 7 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Drug ineffective SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Human papilloma virus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View