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 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
NCT ID:
NCT03857256
Description:
None
Frequency Threshold:
0
Time Frame:
The time period covered was from the first dose of IP to safety follow-up visit (week 14).
Study:
NCT03857256
Study Brief:
Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | matching placebo for 12 weeks. Placebo: tablet manufactured to mimic the CP105F beta-glucan | 0 | None | 1 | 65 | 36 | 65 | View |
| Oat Beta-glucan 1.5g | CP105F (Oat beta-glucan) 1.5g (1 tablet of 0.5g TID) for 12 weeks. CP105F: Natural Health Product | 0 | None | 0 | 64 | 30 | 64 | View |
| Oat Beta-glucan 3g. | CP105F (Oat beta-glucan) 3g (2 tablets of 0.5g TID) for 12 weeks. CP105F: Natural Health Product | 0 | None | 0 | 66 | 36 | 66 | View |
| Oat Beta-glucan 6g. | CP105F (Oat beta-glucan) 6g (4 tablets of 0.5g TID) for 12 weeks. CP105F: Natural Health Product | 0 | None | 2 | 66 | 48 | 66 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Transient Ischemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Faeces soft | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Frequent bowel movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Diabetes Mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Diabetes Mellitus Inadequate Control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Infrequent bowel movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Rectal tenesmus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |