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 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
NCT ID:
NCT00234104
Description:
None
Frequency Threshold:
5.0
Time Frame:
7 days
Study:
NCT00234104
Study Brief:
A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 15 mg of OPC-41061 | OPC-41061 15 mg/day | None | None | 0 | 28 | 21 | 28 | View |
| 30 mg of OPC-41061 | OPC-41061 30 mg/day | None | None | 1 | 33 | 25 | 33 | View |
| Placebo | OPC-41061 0 mg/day | None | None | 4 | 29 | 14 | 29 | View |
| 45 mg of OPC-41061 | OPC-41061 45 mg/day | None | None | 2 | 28 | 21 | 28 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1J | View |
| Cardiac Failure Congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1J | View |
| Cardio-Respiratory Arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1J | View |
| Umbilical Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1J | View |
| Sudden Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1J | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1J | View |
| Dyspnoea Exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1J | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac Failure Congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.1)J | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1)J | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1)J | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1)J | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1)J | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1)J | View |
| Thirst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1)J | View |
| Blood Creatine Phosphokinase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Blood Glucose Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Blood Lactate Dehydrogenase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Blood Osmolarity Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Blood Potassium Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Blood Pressure Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Blood Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Blood Urea Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Blood Uric Acid Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Gamma-Glutamyltransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Lymphocyte Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Platelet Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Protein Urine Present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1)J | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1)J | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1)J | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1)J | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1)J | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1)J | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1)J | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1)J | View |