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 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
NCT ID:
NCT01918332
Description:
All adverse events were collected at every visit by interview, physical assessment and laboratory tests .
The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
Frequency Threshold:
0
Time Frame:
12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
Study:
NCT01918332
Study Brief:
Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and 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 |
|---|---|---|---|---|---|---|---|---|
| Valsartan 160mg, Rosuvastatin 20mg | Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks. Valsartan 160mg Rosuvastatin 20mg | None | None | 1 | 43 | 10 | 43 | View |
| Valsartan 160mg, Rosuvastatin 20mg Placebo | Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. Valsartan 160mg Rosuvastatin 20mg placebo | None | None | 0 | 41 | 7 | 41 | View |
| Valsartan 160mg Placebo, Rosuvastatin 20mg | Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks. Rosuvastatin 20mg Valsartan 160mg placebo | None | None | 0 | 37 | 4 | 37 | View |
| Placebo | Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. Valsartan 160mg placebo Rosuvastatin 20mg placebo | None | None | 0 | 45 | 5 | 45 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 15.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| conjunctival haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 15.1 | View |
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 15.1 | View |
| dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 15.1 | View |
| nasopharyngisit | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 15.1 | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 15.1 | View |
| asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 15.1 | View |
| chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 15.1 | View |
| chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 15.1 | View |
| face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 15.1 | View |
| oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 15.1 | View |
| urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 15.1 | View |
| contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 15.1 | View |
| alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 15.1 | View |
| aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 15.1 | View |
| blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 15.1 | View |
| blood potassium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 15.1 | View |
| gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 15.1 | View |
| musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | View |
| pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 15.1 | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 15.1 | View |
| hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 15.1 | View |
| anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 15.1 | View |
| upper respiratory tract inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | View |