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 @ 5:12 PM
Ignite Modification Date:
2025-12-25 @ 2:50 PM
NCT ID:
NCT00441350
Description:
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
Frequency Threshold:
1
Time Frame:
The study consisted of two sequential phases A and B of 8 weeks duration each.
Study:
NCT00441350
Study Brief:
Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase B OM/HCTZ 40/12.5 mg Responders | Phase B (second double-blind treatment phase, 8 weeks duration): Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg. | 0 | None | 3 | 336 | 16 | 336 | View |
| Phase B OM 40 mg Non-responders | Phase B (second double-blind treatment phase, 8 weeks duration): Non-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg. | 0 | None | 0 | 139 | 6 | 139 | View |
| Phase B OM 40 mg Responders | Phase B (second double-blind treatment phase, 8 weeks duration): Responders to OM 40 mg treatment were to continue treatment with OM 40 mg. | 0 | None | 2 | 129 | 8 | 129 | View |
| Phase A OM/HCTZ 40/12.5 mg | Phase A (first double-blind treatment phase, 8 weeks duration): Arm 2: OM/HCTZ 40/12.5 mg tablet o.d. | 0 | None | 4 | 561 | 41 | 561 | View |
| Phase A OM 40 mg | Phase A (first double-blind treatment phase, 8 weeks duration): Arm 1: OM 40 mg tablet o.d. | 0 | None | 5 | 285 | 19 | 285 | View |
| Phase B OM/HCTZ 40/12.5 mg Non-responders | Phase B (second double-blind treatment phase, 8 weeks duration): Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg. | 0 | None | 1 | 188 | 9 | 188 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anal fissure | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Upper limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Atrial flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Uterine leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Duodenal ulcer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Ischaemic cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Brain contusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Incontinence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Parotid abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Erysipeloid | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |