TriangleNCT00661999 · OUTCOME
Time to Hematopoietic Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 16 weeks
What was measured
Hematopoietic response was defined as Hb increment of 2.0 g/dL from baseline or achievement of Hb \>= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.
Groups in this outcome
DA + IV Iron
Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
DA + Oral Iron
Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
DA + Placebo
Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
| Group | Source count |
|---|---|
| DA + IV Iron | 164 |
| DA + Oral Iron | 163 |
| DA + Placebo | 163 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DA + IV Iron | 43 | Not reported | 36 | 55 | Not reported |
| DA + Oral Iron | 61 | Not reported | 55 | 73 | Not reported |
| DA + Placebo | 50 | Not reported | 42 | 64 | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0648
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0648
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36
- upper Limit
- 55
- value
- 43
- group Id
- OG001
- lower Limit
- 55
- upper Limit
- 73
- value
- 61
- group Id
- OG002
- lower Limit
- 42
- upper Limit
- 64
- value
- 50
- denoms
- counts
- group Id
- OG000
- value
- 164
- group Id
- OG001
- value
- 163
- group Id
- OG002
- value
- 163
- units
- Participants
- description
- Hematopoietic response was defined as Hb increment of 2.0 g/dL from baseline or achievement of Hb \>= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
- id
- OG000
- title
- DA + IV Iron
- description
- Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
- id
- OG001
- title
- DA + Oral Iron
- description
- Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
- id
- OG002
- title
- DA + Placebo
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- 16 weeks
- title
- Time to Hematopoietic Response
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice