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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| L100/H12.5→L100/H12.5 Open Label (Period 2) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension | None | None | 1 | 127 | 43 | 127 | View |
| L50/H12.5→L100/H12.5 Open Label (Period 2) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension) | None | None | 6 | 131 | 47 | 131 | View |
| MK-0954H (L50/H12.5) Double Blind Period (Period 1) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5) | None | None | 1 | 144 | 18 | 144 | View |
| MK-0954A (L100/H12.5) Double Blind Period (Period 1) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5) | None | None | 2 | 134 | 20 | 134 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abscess neck | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Limb crushing injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Spinal column stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Upper respiratory tract inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |