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:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT00107900
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00107900
Study Brief:
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 15mg BID | 15mg edoxaban administered twice daily (BID) | None | None | 4 | 85 | 24 | 85 | View |
| 30mg QD | 30mg edoxaban administered once daily (QD) | None | None | 3 | 75 | 19 | 75 | View |
| 30mg BID | 30mg edoxaban administered twice daily (BID) | None | None | 9 | 129 | 65 | 129 | View |
| 60mg QD | 60mg edoxaban administered once daily (QD) | None | None | 10 | 99 | 56 | 99 | View |
| 60mg BID | 60mg edoxaban administered twice daily (BID) | None | None | 10 | 115 | 66 | 115 | View |
| 120mg QD | 120mg edoxaban administered once daily (QD) | None | None | 4 | 103 | 34 | 103 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.1) | View |
| blood alkaline phosphatase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| alanine aminotransferase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| blood bilirubin abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| aspartate amniotransferase abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| hepatic enzyme increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| sciatic nerve palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| snake bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| contrast media reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| wound haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.1) | View |
| postprocedural fistula | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| acute psychosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| anemia postoperative | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| lymphadentis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.1) | View |
| infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| hip arthroplasty | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| alanine aminotransferase increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| blood alkaline phosphatase increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.1) | View |
| chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| pallor | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.1) | View |
| obstructive inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| dislocation of joint prosthesis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.1) | View |
| wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.1) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| hyperthermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| prothrombin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.1) | View |
| anaemia post-operative | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |