TriangleNCT00717366 · OUTCOME
Change in Average Reticulocyte Count Between the Baseline and Evaluation Period
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- 10^3 cells/microliter
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
What was measured
A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.
Analysis population: ITT population. Reticulocyte values within 21 days after blood transfusion(s) were excluded from analysis. Here, number of participants analyzed = participants evaluable for this outcome measure and 'n' signifies number of participants evaluable at specified time-points.
Groups in this outcome
MIRCERA Group 1: Intermediate-Conversion-Factor Group
Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \* previous weekly epoetin dose \[IU\]/250 or 4 \* previous weekly darbepoetin alfa dose \[mcg\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
MIRCERA Group 2: High-Conversion-Factor Group
Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \* previous weekly epoetin dose \[IU\]/125 or 4 \* previous weekly darbepoetin alfa dose \[mcg\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
| Group | Source count |
|---|---|
| MIRCERA Group 1: Intermediate-Conversion-Factor Group | 15 |
| MIRCERA Group 2: High-Conversion-Factor Group | 48 |
Reported measurements
Baseline (n=15,48)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MIRCERA Group 1: Intermediate-Conversion-Factor Group | 46.08 | 26.472 | Not reported | Not reported | Not reported |
| MIRCERA Group 2: High-Conversion-Factor Group | 43.70 | 25.984 | Not reported | Not reported | Not reported |
Change at Evaluation Period (n=11,36)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MIRCERA Group 1: Intermediate-Conversion-Factor Group | 23.38 | 29.279 | Not reported | Not reported | Not reported |
| MIRCERA Group 2: High-Conversion-Factor Group | 24.80 | 32.428 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 26.472
- value
- 46.08
- group Id
- OG001
- spread
- 25.984
- value
- 43.70
- title
- Baseline (n=15,48)
- categories
- measurements
- group Id
- OG000
- spread
- 29.279
- value
- 23.38
- group Id
- OG001
- spread
- 32.428
- value
- 24.80
- title
- Change at Evaluation Period (n=11,36)
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 48
- units
- Participants
- description
- A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \* previous weekly epoetin dose \[IU\]/250 or 4 \* previous weekly darbepoetin alfa dose \[mcg\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
- id
- OG000
- title
- MIRCERA Group 1: Intermediate-Conversion-Factor Group
- description
- Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \* previous weekly epoetin dose \[IU\]/125 or 4 \* previous weekly darbepoetin alfa dose \[mcg\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
- id
- OG001
- title
- MIRCERA Group 2: High-Conversion-Factor Group
- param Type
- MEAN
- population Description
- ITT population. Reticulocyte values within 21 days after blood transfusion(s) were excluded from analysis. Here, number of participants analyzed = participants evaluable for this outcome measure and 'n' signifies number of participants evaluable at specified time-points.
- reporting Status
- POSTED
- time Frame
- Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
- title
- Change in Average Reticulocyte Count Between the Baseline and Evaluation Period
- type
- SECONDARY
- unit Of Measure
- 10^3 cells/microliter
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Preserved source evidence · Not medical advice