NCT00123487 · OUTCOME
Median Time to Major Hematologic Response (MaHR) - Randomized Population
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 up to 6 months (time of primary endpoint), 2 years
What was measured
A participants' time to MaHR was defined as the time from the first dosing date until criteria are first met for CHR or NEL, whichever occurred first. Non-responders were censored at the maximum of the date of last hematologic or cytogenetic assessment. Median time was measured in months.
Analysis population: Participants were analyzed based on the treatment they were randomized to receive.
Groups in this outcome
Dasatinib 140 mg QD
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
Dasatinib 70 mg BID
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
| Group | Source count |
|---|---|
| Dasatinib 140 mg QD | 306 |
| Dasatinib 70 mg BID | 305 |
Reported measurements
6 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 140 mg QD | 1.9 | Not reported | 1.8 | 1.9 | Not reported |
| Dasatinib 70 mg BID | 1.9 | Not reported | 1.5 | 2.0 | Not reported |
2 Years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 140 mg QD | 1.9 | Not reported | 1.8 | 1.9 | Not reported |
| Dasatinib 70 mg BID | 1.9 | Not reported | 1.6 | 2.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- 1.9
- value
- 1.9
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 2.0
- value
- 1.9
- title
- 6 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- 1.9
- value
- 1.9
- group Id
- OG001
- lower Limit
- 1.6
- upper Limit
- 2.1
- value
- 1.9
- title
- 2 Years
- denoms
- counts
- group Id
- OG000
- value
- 306
- group Id
- OG001
- value
- 305
- units
- Participants
- description
- A participants' time to MaHR was defined as the time from the first dosing date until criteria are first met for CHR or NEL, whichever occurred first. Non-responders were censored at the maximum of the date of last hematologic or cytogenetic assessment. Median time was measured in months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
- id
- OG000
- title
- Dasatinib 140 mg QD
- description
- Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
- id
- OG001
- title
- Dasatinib 70 mg BID
- param Type
- MEDIAN
- population Description
- Participants were analyzed based on the treatment they were randomized to receive.
- reporting Status
- POSTED
- time Frame
- Day 1 up to 6 months (time of primary endpoint), 2 years
- title
- Median Time to Major Hematologic Response (MaHR) - Randomized Population
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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