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 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
NCT ID:
NCT01181102
Description:
The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Frequency Threshold:
2
Time Frame:
None
Study:
NCT01181102
Study Brief:
A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| DU-176b | DU-176b oral tablets, 30 mg., taken once daily for 2 weeks edoxaban | None | None | 10 | 354 | 237 | 354 | View |
| Enoxaparin Sodium | enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks enoxaparin sodium | None | None | 11 | 349 | 256 | 349 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| retinal artery occlusion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA JV12.0 | View |
| cyanosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA JV12.0 | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA JV12.0 | View |
| gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA JV12.0 | View |
| melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA JV12.0 | View |
| urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA JV12.0 | View |
| joint contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA JV12.0 | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA JV12.0 | View |
| postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA JV12.0 | View |
| stitch abcess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA JV12.0 | View |
| carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA JV12.0 | View |
| cerebellar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA JV12.0 | View |
| convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA JV12.0 | View |
| syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA JV12.0 | View |
| myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA JV12.0 | View |
| deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA JV12.0 | View |
| pyoderma gangrenosum | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA JV12.0 | View |
| haemarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA JV12.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA JV12.0 | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA JV12.0 | View |
| Wound complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA JV12.0 | View |
| Ligament rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA JV12.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| Blood triglycerides increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| blood urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA JV12.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA JV12.0 | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA JV12.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA JV12.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA JV12.0 | View |
| wound haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA JV12.0 | View |
| Haemorrhage subcutaneous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA JV12.0 | View |
| Haemarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA JV12.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA JV12.0 | View |