TriangleNCT00559273 · OUTCOME
Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline to Week 28
What was measured
The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and \>=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were \>=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.
Analysis population: ITT population. Here, N=number of participants analyzed for this measure.
Groups in this outcome
Mircera
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
Darbepoetin Alfa
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
| Group | Source count |
|---|---|
| Mircera | 105 |
| Darbepoetin Alfa | 112 |
Reported measurements
Dose Increase(s) only
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Mircera | 41.9 | Not reported | Not reported | Not reported | Not reported |
| Darbepoetin Alfa | 18.8 | Not reported | Not reported | Not reported | Not reported |
Dose Decrease(s) only
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Mircera | 8.6 | Not reported | Not reported | Not reported | Not reported |
| Darbepoetin Alfa | 19.6 | Not reported | Not reported | Not reported | Not reported |
Dose Decrease(s) and Increase(s)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Mircera | 11.4 | Not reported | Not reported | Not reported | Not reported |
| Darbepoetin Alfa | 18.8 | Not reported | Not reported | Not reported | Not reported |
No Dose Change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Mircera | 38.1 | Not reported | Not reported | Not reported | Not reported |
| Darbepoetin Alfa | 42.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 41.9
- group Id
- OG001
- value
- 18.8
- title
- Dose Increase(s) only
- categories
- measurements
- group Id
- OG000
- value
- 8.6
- group Id
- OG001
- value
- 19.6
- title
- Dose Decrease(s) only
- categories
- measurements
- group Id
- OG000
- value
- 11.4
- group Id
- OG001
- value
- 18.8
- title
- Dose Decrease(s) and Increase(s)
- categories
- measurements
- group Id
- OG000
- value
- 38.1
- group Id
- OG001
- value
- 42.9
- title
- No Dose Change
- denoms
- counts
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 112
- units
- Participants
- description
- The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and \>=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were \>=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.
- groups
- description
- Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
- id
- OG000
- title
- Mircera
- description
- Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
- id
- OG001
- title
- Darbepoetin Alfa
- param Type
- NUMBER
- population Description
- ITT population. Here, N=number of participants analyzed for this measure.
- reporting Status
- POSTED
- time Frame
- Baseline to Week 28
- title
- Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice