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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| UST Open Label | Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase. | 0 | None | 2 | 108 | 4 | 108 | View |
| Post Randomization: UST, ABA/UST Placebo | Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (ABA) (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28. | 0 | None | 2 | 45 | 6 | 45 | View |
| Post Randomization: UST, UST/ABA Placebo | Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept (ABA) placebo subcutaneous injections weekly from Week 12 to 39. | 0 | None | 5 | 46 | 6 | 46 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cervical spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Post procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 17.0 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 17.0 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 17.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 17.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |