TriangleNCT00123474 · OUTCOME
Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up
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
- 95% Confidence Interval
- Time frame
- 24 months
What was measured
Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets \< 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); \< 5% myelocytes plus metamyelocytes in PB; Basophils in PB \< 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date. No cytogenic assessments were made after 2 years of follow-up.
Analysis population: All randomized participants were summarized.
Groups in this outcome
QD Dasatinib
Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
BID Dasatinib
Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
Total Daily Dose 100 mg
Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
Total Daily Dose 140 mg
Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
| Group | Source count |
|---|---|
| QD Dasatinib | 334 |
| BID Dasatinib | 336 |
| Total Daily Dose 100 mg | 335 |
| Total Daily Dose 140 mg | 335 |
Reported measurements
MCyR(n=334,336,335,335)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| QD Dasatinib | 63.2 | Not reported | 57.8 | 68.4 | Not reported |
| BID Dasatinib | 61.3 | Not reported | 55.9 | 66.5 | Not reported |
| Total Daily Dose 100 mg | 62.4 | Not reported | 57.0 | 67.6 | Not reported |
| Total Daily Dose 140 mg | 62.1 | Not reported | 56.7 | 67.3 | Not reported |
CHR (n=334,336,335,335)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| QD Dasatinib | 89.2 | Not reported | 85.4 | 92.3 | Not reported |
| BID Dasatinib | 90.2 | Not reported | 86.5 | 93.1 | Not reported |
| Total Daily Dose 100 mg | 91.9 | Not reported | 88.5 | 94.6 | Not reported |
| Total Daily Dose 140 mg | 87.5 | Not reported | 83.4 | 90.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 57.8
- upper Limit
- 68.4
- value
- 63.2
- group Id
- OG001
- lower Limit
- 55.9
- upper Limit
- 66.5
- value
- 61.3
- group Id
- OG002
- lower Limit
- 57.0
- upper Limit
- 67.6
- value
- 62.4
- group Id
- OG003
- lower Limit
- 56.7
- upper Limit
- 67.3
- value
- 62.1
- title
- MCyR(n=334,336,335,335)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 85.4
- upper Limit
- 92.3
- value
- 89.2
- group Id
- OG001
- lower Limit
- 86.5
- upper Limit
- 93.1
- value
- 90.2
- group Id
- OG002
- lower Limit
- 88.5
- upper Limit
- 94.6
- value
- 91.9
- group Id
- OG003
- lower Limit
- 83.4
- upper Limit
- 90.8
- value
- 87.5
- title
- CHR (n=334,336,335,335)
- denoms
- counts
- group Id
- OG000
- value
- 334
- group Id
- OG001
- value
- 336
- group Id
- OG002
- value
- 335
- group Id
- OG003
- value
- 335
- units
- Participants
- description
- Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets \< 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); \< 5% myelocytes plus metamyelocytes in PB; Basophils in PB \< 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date. No cytogenic assessments were made after 2 years of follow-up.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG000
- title
- QD Dasatinib
- description
- Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG001
- title
- BID Dasatinib
- description
- Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG002
- title
- Total Daily Dose 100 mg
- description
- Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG003
- title
- Total Daily Dose 140 mg
- param Type
- NUMBER
- population Description
- All randomized participants were summarized.
- reporting Status
- POSTED
- time Frame
- 24 months
- title
- Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice