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:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
NCT ID:
NCT01083693
Description:
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
Frequency Threshold:
0
Time Frame:
Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
Study:
NCT01083693
Study Brief:
Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. | None | None | 6 | 93 | 10 | 93 | View |
| Ankylosing Spondylitis (AS) | Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs. | None | None | 0 | 40 | 1 | 40 | View |
| Total | None | None | None | 8 | 161 | 12 | 161 | View |
| Psoriasis Arthritis (PsA) | Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. | None | None | 2 | 28 | 1 | 28 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Post procedural sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| Ulcer | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Arthroscopy | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.0 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| Leg amputation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 13.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| Uriticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| Synovectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 13.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| Procedural site reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.0 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |