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 @ 11:53 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
NCT ID:
NCT03649061
Description:
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
Frequency Threshold:
5
Time Frame:
(Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
Study:
NCT03649061
Study Brief:
COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Standard COBRA-Slim Induction | Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.) Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme | 1 | None | 4 | 55 | 43 | 55 | View |
| COBRA-Slim Bio-induction | Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.) Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme | 1 | None | 5 | 55 | 47 | 55 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| aortic dissection | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| myocardial ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| psychiatric decompensation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.1) | View |
| bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| enterococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| stress cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| cerobrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| erythema multiforme | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |