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 @ 2:35 PM
Ignite Modification Date: 2025-12-25 @ 1:07 PM
NCT ID: NCT01671059
Description: An adverse event is any unfavorable or unintended sign or symptom associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT01671059
Study Brief: A Non-Interventional Study Evaluating Rheumatoid Arthritis Participants Treated With Tocilizumab (RoActemra/Actemra)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tocilizumab Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice. None None 11 80 11 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Medication error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Acetabulum fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Gamma-Glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gynaecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Lack of drug effect SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Diabetic foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View