Comparison · NCT01977573-34b5c55d
rhEPO-Naive GSK1278863 vs rhEPO-User GSK1278863: Number of Participants With at Least One Dose Cycle up to 24 Weeks
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. rhEPO-Naive GSK1278863 vs rhEPO-User GSK1278863: Number of Participants With at Least One Dose Cycle up to 24 Weeks. Trial comparisons, record NCT01977573-34b5c55d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01977573-34b5c55d
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00943 | 0.00167 | 0.0515 | wilson | |
| Risk in group 2 | 0 | 0 | 0.114 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00943 | -0.104 | 0.0515 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on rhEPO-Naive GSK1278863 than on rhEPO-User GSK1278863 | 106 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | rhEPO-Naive GSK1278863 | RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28. | 1 | 106 | OG000 |
| Group 2 | rhEPO-User GSK1278863 | RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason \[based on Investigator's opinion\] to start rhEPO therapy). | 0 | 30 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With at Least One Dose Cycle up to 24 Weeks
- Description
- A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease). participants
- Time frame
- Up to 24 weeks
- Population
- Completers population. Only participants in the GSK1278863 arms with dose cycles were analyzed.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
- NCT number
- NCT01977573
- Phases
- PHASE2
- Conditions
- Anaemia
- Interventions
- GSK1278863, rhEPO
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2016-06-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01977573?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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