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 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
NCT ID:
NCT00892957
Description:
None
Frequency Threshold:
5
Time Frame:
Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.
Study:
NCT00892957
Study Brief:
FS VH S/D 500 S-apr in Vascular Surgery
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| FS VH S/D 500 S-apr | FS VH S/D 500 s-apr will be applied to the study suture line. | None | None | 20 | 70 | 14 | 70 | View |
| Control - Manual Compression With Surgical Gauze Pads | Dry gauze pads will be positioned to cover the complete study suture line. | None | None | 18 | 70 | 7 | 70 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | None | Cardiac disorders | MedDRA (Unspecified) | View |
| Cardiac failure congestive | None | Cardiac disorders | MedDRA (Unspecified) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Haematemesis | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Non-cardiac chest pain | None | General disorders | MedDRA (Unspecified) | View |
| Thrombosis in device | None | General disorders | MedDRA (Unspecified) | View |
| Appendicitis perforated | None | Infections and infestations | MedDRA (Unspecified) | View |
| Staphylococcal sepsis | None | Infections and infestations | MedDRA (Unspecified) | View |
| Wound infection staphylococcal | None | Infections and infestations | MedDRA (Unspecified) | View |
| Femoral neck fracture | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Postoperative wound infection | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Spinal compression fracture | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Vascular graft occlusion | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Vascular graft thrombosis | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Hyponatraemia | None | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Ischaemic neuropathy | None | Nervous system disorders | MedDRA (Unspecified) | View |
| Acute pulmonary oedema | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Respiratory distress | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Arterial thrombosis limb | None | Vascular disorders | MedDRA (Unspecified) | View |
| Haematoma | None | Vascular disorders | MedDRA (Unspecified) | View |
| Steal syndrome | None | Vascular disorders | MedDRA (Unspecified) | View |
| Cardio-respiratory arrest | None | Cardiac disorders | MedDRA (Unspecified) | View |
| Small intestinal obstruction | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Small intestinal perforation | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Multi-organ failure | None | General disorders | MedDRA (Unspecified) | View |
| Sepsis | None | Infections and infestations | MedDRA (Unspecified) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (Unspecified) | View |
| Drug toxicity | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Graft thrombosis | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Incision site cellulitis | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| International normalised ratio increased | None | Investigations | MedDRA (Unspecified) | View |
| Hypovolaemia | None | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Pneumonia aspiration | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |