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 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
NCT ID:
NCT01104558
Description:
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Frequency Threshold:
0
Time Frame:
Up to Week 26 (or EOT)
Study:
NCT01104558
Study Brief:
Association Between Genetic Polymorphism of Beta-adrenergic Receptor and Effects of Bisoprolol in Korean Heart Failure Patients.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Bisoprolol | Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day. | None | None | 7 | 100 | 93 | 100 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Death sudden | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| INR increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Hospitalisation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Diabetic retinopathy | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.1) | View |
| Keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.1) | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Epigastric discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Gingival bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| General body pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Pitting edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Weakness generalized | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Hypertriglyceridemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Back discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Shoulder pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Dysarthria | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Head discomfort | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Near syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Orthostatic dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Sleepiness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Slurred speech | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Tingling feet/hands | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Voiding difficulty | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.1) | View |
| Nipple pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (14.1) | View |
| Common cold | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Dry cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Sputum | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.1) | View |