Trial · NCT01977573
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 30 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Mean Total Cumulative Dose of GSK1278863 up to 24 Weeks | Up to 24 Weeks | The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. |
| Secondary | Mean Final Dose of GSK1278863 up to 24 Weeks | Up to 24 Weeks | The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. |
| Secondary | Number of Hemoglobin (Hgb) Excursions | Up to 24 Weeks. | A Hgb excursion is a series of decreasing or increasing Hgb values differing by \>=1.5 grams per deciliter. Hgb cycle is calculated as two consecutive Hgb excursions in different directions. |
| Secondary | Number of Hemoglobin (Hgb) Cycles up to 24 Weeks | Up to 24 Weeks | A Hgb cycle is calculated as two consecutive Hgb excursions in different directions. A Hgb excursion is a series of decreasing or increasing Hgb values differing by \>=1.5 grams per deciliter. |
| Secondary | Number of Dose Cycles up to 24 Weeks | Up to 24 weeks | A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease). |
| Secondary | Number of Participants With at Least One Hemoglobin (Hgb) Excursion up to 24 Weeks. | Up to 24 weeks | A Hgb excursion is a series of decreasing or increasing Hgb values differing by \>=1.5 grams per deciliter. |
| Secondary | Number of Participants With at Least One Hemoglobin (Hgb) Cycle up to 24 Weeks | Up to 24 weeks | A Hgb excursion is a series of decreasing or increasing Hgb values differing by \>=1.5 grams per deciliter. A Hgb cycle is two consecutive Hgb excursions in different directions. |
| Secondary | Number of Participants With at Least One Dose Cycle up to 24 Weeks | Up to 24 weeks | A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease). participants |
| Secondary | Number of Participants Receiving Additional Therapies of Blood Transfusions, Intravenous (IV) Iron or rhEPO at Any Time Post-Baseline | From Day 1 up to Week 28 | Participants receiving additional therapies of blood transfusions, intravenous (IV) iron or rhEPO any time Post Baseline were analyzed. RhEPO was not applicable for the control arms since it was a planned therapy in those arms, hence presented as NA. (EudraCT only: A value of 99999 is used where no data is available or NA.) |
| Secondary | Number of Weeks Dose Withheld Because Hemoglobin (Hgb) Exceeded the Upper Limit | From Week 4 up to Week 24 | Number of Weeks dose was withheld because hemoglobin exceed the upper limit is presented as the number of participants with withheld dose during the time periods categorized by Weeks. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01977573/registered?page=2