Trial · NCT01416194
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Incidence of Venous Thromboembolism (VTE) | Up to a maximum of follow-up period of 92.1 months | VTE is defined as deep vein thrombosis (DVT), pulmonary embolism (PE), retinal vein thrombosis, and sinus thrombosis. DVT: occurs when a blood clot forms in a vein located deep inside the body. PE: a blockage of an artery in the lungs by a substance that has moved from elsewhere in the body through the bloodstream (embolism). Sinus thrombosis: presence of a blood clot in the dural venous sinuses, which drain blood from the brain. Retinal vein thrombosis: blockage of the small veins that carry blood away from the retina. Cumulative incidence was calculated as total participants with VTE events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Ischemic Stroke | Up to a maximum of follow-up period of 92.1 months | Ischemic stroke is caused by a blockage in an artery that supplies blood to the brain. Cumulative incidence was calculated as total participants with ischemic stroke events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Cardiac Disorders | Up to a maximum of follow-up period of 92.1 months | Cardiac disorders included myocardial infarction, myocardial ischemia, and coronary occlusion. Cumulative incidence was calculated as total participants with cardiac disorders events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Atrial Fibrillation | Up to a maximum of follow-up period of 92.1 months | Atrial fibrillation is an irregular heartbeat that increases the risk of stroke and heart disease. Cumulative incidence was calculated as total participants with atrial fibrillation events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Biliary Events | Up to a maximum of follow-up period of 92.1 months | Biliary events included cholecystitis and cholelithiasis. Cumulative incidence was calculated as total participants with biliary events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Hypertriglyceridemia | Up to a maximum of follow-up period of 92.1 months | Hypertriglyceridemia refers to high blood levels of triglycerides. Cumulative incidence was calculated as total participants with hypertriglyceridemia events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Clinical Fractures | Up to a maximum of follow-up period of 92.1 months | A fracture is a break in a bone. Cumulative incidence was calculated as total participants with clinical fractures events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Renal Failure | Up to a maximum of follow-up period of 92.1 months | Cumulative incidence was calculated as total participants with renal failure events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of All Malignancies | Up to a maximum of follow-up period of 92.1 months | All malignancies included and not limited only to thyroid, breast, renal, genital / urogenital, lung cancer, gastrointestinal tract and respiratory tract. Cumulative incidence was calculated as total participants with malignancies events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Different Types of Malignancies | Up to a maximum of follow-up period of 92.1 months | In this outcome measure, cumulative incidence of different types of malignancies included breast, renal, thyroid, genital / urogenital, gastrointestinal tract, lung and respiratory tract were calculated. Cumulative incidence for each type of malignancy was calculated as total participant with the respective malignancy events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence for each type of malignancy was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Depression | Up to a maximum of follow-up period of 92.1 months | Cumulative incidence was calculated as total participants with depression events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Selected Ocular Events | Up to a maximum of follow-up period of 92.1 months | Selected ocular events included retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea. Cumulative incidence was calculated as total participants with selected ocular events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
| Secondary | Cumulative Incidence of Thyroid Disorders- Goitre | Up to a maximum of follow-up period of 92.1 months | Goitre is a swelling in the neck resulting from an enlarged thyroid gland. Cumulative incidence was calculated as total participants with thyroid disorders-goitre events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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