TriangleNCT00717366 · OUTCOME
Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Evaluation Period (Week 17 to Week 21)
What was measured
The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).
Analysis population: ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment 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 | 12 |
| MIRCERA Group 2: High-Conversion-Factor Group | 36 |
Reported measurements
Above 12 g/dL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MIRCERA Group 1: Intermediate-Conversion-Factor Group | 0 | Not reported | Not reported | Not reported | Not reported |
| MIRCERA Group 2: High-Conversion-Factor Group | 3 | Not reported | Not reported | Not reported | Not reported |
Within 10-12 g/dL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MIRCERA Group 1: Intermediate-Conversion-Factor Group | 9 | Not reported | Not reported | Not reported | Not reported |
| MIRCERA Group 2: High-Conversion-Factor Group | 29 | Not reported | Not reported | Not reported | Not reported |
Below 10 g/dL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MIRCERA Group 1: Intermediate-Conversion-Factor Group | 3 | Not reported | Not reported | Not reported | Not reported |
| MIRCERA Group 2: High-Conversion-Factor Group | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- title
- Above 12 g/dL
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 29
- title
- Within 10-12 g/dL
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- title
- Below 10 g/dL
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 36
- units
- Participants
- description
- The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).
- 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
- NUMBER
- population Description
- ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.
- reporting Status
- POSTED
- time Frame
- Evaluation Period (Week 17 to Week 21)
- title
- Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice