Trial · NCT02680756
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Baseline to Week 12 | Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women,\>=13g/dL men) at Week 12 |
| Primary | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Baseline to Week 12 | Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women, \>=13g/dL men) at Week 12 |
| Secondary | Change in Hb Concentration From Baseline to Week 12 | Baseline to Week 12 | Change in hemoglobin concentration from baseline to Week 12. |
| Secondary | Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL | Baseline to Week 12 | Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin \<9.5 g/dL. |
| Secondary | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12 | Baseline to Week 12 | Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 12. |
| Secondary | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12 | Baseline to Week 12 | Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 12. |
| Secondary | Number of Subjects With Hb Concentration Within Normal Limits at Week 12 | Baseline to Week 12 | Number of subjects with Hb concentration within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men) |
| Secondary | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12 | Baseline to Week 12 | Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men) |
| Secondary | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | Baseline to Month 6 | Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 months and 12 months (normal limit definition: \>=12g/dL women, \>=13g/dL men) |
| Secondary | Change in Hb Concentration From Baseline to Week 4 | Baseline to Week 4 | Change in hemoglobin concentration from baseline to Week 4. |
| Secondary | Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL | Baseline to Week 4 | Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin \<9.5 g/dL. |
| Secondary | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12 | Baseline to Week 12 | Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 12. |
| Secondary | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12 | Baseline to Week 12 | Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 12. |
| Secondary | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4 | Baseline to Week 4 | Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 4. |
| Secondary | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4 | Baseline to Week 4 | Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 4. |
| Secondary | Number of Subjects With Hb Concentration Within Normal Limits at Week 4 | Baseline to Week 4 | Number of subjects with Hb concentration within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men) |
| Secondary | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4 | Baseline to Week 4 | Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men) |
| Secondary | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4 | Baseline to Week 4 | Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 4. |
| Secondary | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4 | Baseline to Week 4 | Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 4 |
| Other | Change From Baseline Physical Component and Mental Component Score | Baseline to Week 52 (LOCF) | A multipurpose, proprietary health survey with 36 questions. It was constructed to survey health status in the Medical Outcomes Study and designed for use in clinical practice and research \& general population surveys. The SF-36 includes one multi-item scale that assesses 8 health components: Physical Functioning Component; Social Functioning Component; Role-Physical Component; Bodily Pain Component; Mental Health Component; Role-Emotional Component; Vitality Component; \& General Health Component. These 8 health component scales can be further summarised into 2 summary scores, the Mental Component Score \& the Physical Component Score where higher values mean a better outcome. Both scales range from 0 to 100, where higher scores indicate better health status. The survey will be administered at study visits as indicated in the schedule of assessments, commencing pre-randomization at Visit 2. The survey will be completed by the subjects in their native language. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02680756/registered