TriangleNCT00717366 · OUTCOME
Change in Average Hb Concentration Between 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
- g/dL
- 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 Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.
Analysis population: ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis.
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 | 16 |
| MIRCERA Group 2: High-Conversion-Factor Group | 48 |
Reported measurements
Baseline (n=16,48)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MIRCERA Group 1: Intermediate-Conversion-Factor Group | 11.26 | 0.496 | Not reported | Not reported | Not reported |
| MIRCERA Group 2: High-Conversion-Factor Group | 11.08 | 0.493 | Not reported | Not reported | Not reported |
Change at Evaluation Period (n=12,36)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MIRCERA Group 1: Intermediate-Conversion-Factor Group | -0.78 | 1.237 | Not reported | Not reported | Not reported |
| MIRCERA Group 2: High-Conversion-Factor Group | -0.15 | 1.014 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.496
- value
- 11.26
- group Id
- OG001
- spread
- 0.493
- value
- 11.08
- title
- Baseline (n=16,48)
- categories
- measurements
- group Id
- OG000
- spread
- 1.237
- value
- -0.78
- group Id
- OG001
- spread
- 1.014
- value
- -0.15
- title
- Change at Evaluation Period (n=12,36)
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 48
- units
- Participants
- description
- A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.
- 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. Hb values within 21 days after blood transfusion(s) were excluded from analysis.
- reporting Status
- POSTED
- time Frame
- Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
- title
- Change in Average Hb Concentration Between Baseline and Evaluation Period
- type
- PRIMARY
- unit Of Measure
- g/dL
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Preserved source evidence · Not medical advice