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 @ 10:14 PM
Ignite Modification Date: 2025-12-25 @ 7:49 PM
NCT ID: NCT01756235
Description: Non serious adverse events were not collected for this study.
Frequency Threshold: 0
Time Frame: Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Study: NCT01756235
Study Brief: Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Participants With Rheumatoid Arthritis Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice. None None 32 460 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
LEUKOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
THROMBOCYTOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
CARDIAC FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
MYOCARDIAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
CHEST PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
NO THERAPEUTIC RESPONSE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
OEDEMA PERIPHERAL NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
CHOLECYSTITIS ACUTE NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
DRUG HYPERSENSITIVITY NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
HYPERSENSITIVITY NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
BRONCHITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
CYTOMEGALOVIRUS HEPATITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
HERPES OPHTHALMIC NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
LOCALISED INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
PULMONARY TUBERCULOSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
TONSILLITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
VAGINAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
LUPUS-LIKE SYNDROME NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
OSTEOARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
LUNG ADENOCARCINOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
PANCREATIC CARCINOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
INTERCOSTAL NEURALGIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
ISCHAEMIC STROKE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
LOSS OF CONSCIOUSNESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
RENAL FAILURE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
PLEURISY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
ECZEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
ERYTHEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
PHOTODERMATOSIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
PRURITUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
SKIN DISORDER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Other Events(If Any):