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 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
NCT ID:
NCT01517802
Description:
Safety analysis set included participants who received at least 1 dose of study drug.
Frequency Threshold:
0
Time Frame:
Up to 9 years
Study:
NCT01517802
Study Brief:
A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Abiraterone Acetate + Prednisone/Prednisolone | Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 \[NCT00473512\], COU-AA-002 \[NCT00473746\], COU-AA-006 \[NCT00910754\], COU-AA-206 \[NCT01400555\], COU-AA-301 \[NCT00638690\], COU-AA-302 \[NCT00887198\], COU-AA-BMA \[NCT00544440\]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years. | 1 | None | 16 | 31 | 0 | 31 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Aortic Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Lower Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Spinal Cord Compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Cardiac Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Cardiac Failure Congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Urinary Retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Skin Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Upper Limb Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Aortic Valve Replacement | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lower Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Spinal Cord Compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Cardiac Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Cardiac Failure Congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Aortic Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Urinary Retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Skin Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Upper Limb Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Aortic Valve Replacement | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 23.0 | View |