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 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
NCT ID:
NCT00249002
Description:
None
Frequency Threshold:
0
Time Frame:
AEs collected up to 30 days after the last ABI-007 dose administration (Week 21), except for cardiovascular side effects or other events at the investigator's discretion, which would be reported whenever they occur.
Study:
NCT00249002
Study Brief:
Use of ABI-007 for the Prevention of Vascular Access Graft Failure in Patients Undergoing Hemodialysis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ABI-007 | ABI-007 35 mg/m\^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21 | None | None | 6 | 9 | 7 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anastomotic stenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Contrast media reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Graft thrombosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anastomotic stenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Venous stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Colon adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Vascular graft complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Contrast media reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Cardiovascular disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Hypertrophic obstructive cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Facial palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Duodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Oesophageal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |