TriangleNCT00123474 · OUTCOME
Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants
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, 36, 48, 60, 72, and 84 months
What was measured
PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to \> 20,000/mm\^3 or an increase by \> 50,000/mm\^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.
Analysis population: All participants who were randomized to a treatment arm were summarized.
Groups in this outcome
Dasatinib 100 mg QD
Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
Dasatinib 140 mg QD
Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
Dasatinib 50 mg BID
Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
Dasatinib 70 mg BID
Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
| Group | Source count |
|---|---|
| Dasatinib 100 mg QD | 167 |
| Dasatinib 140 mg QD | 167 |
| Dasatinib 50 mg BID | 168 |
| Dasatinib 70 mg BID | 168 |
Reported measurements
24 Months (n=167, 167, 168, 168)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 100 mg QD | 77.4 | Not reported | 69.9 | 83.2 | Not reported |
| Dasatinib 140 mg QD | 67.7 | Not reported | 59.6 | 74.5 | Not reported |
| Dasatinib 50 mg BID | 72.2 | Not reported | 64.3 | 78.7 | Not reported |
| Dasatinib 70 mg BID | 73.9 | Not reported | 66.1 | 80.1 | Not reported |
36 Months (n=167, 167, 168, 168)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 100 mg QD | 66.6 | Not reported | 58.3 | 73.6 | Not reported |
| Dasatinib 140 mg QD | 54.0 | Not reported | 45.4 | 61.8 | Not reported |
| Dasatinib 50 mg BID | 67.5 | Not reported | 59.2 | 74.5 | Not reported |
| Dasatinib 70 mg BID | 62.8 | Not reported | 54.3 | 70.1 | Not reported |
48 Months (n=167, 167, 168, 168)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 100 mg QD | 59.1 | Not reported | 50.6 | 66.6 | Not reported |
| Dasatinib 140 mg QD | 48.0 | Not reported | 39.4 | 56.2 | Not reported |
| Dasatinib 50 mg BID | 63.3 | Not reported | 54.8 | 70.7 | Not reported |
| Dasatinib 70 mg BID | 58.7 | Not reported | 50.1 | 66.3 | Not reported |
60 Months (n=167, 167, 168, 168)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 100 mg QD | 52.5 | Not reported | 43.8 | 60.5 | Not reported |
| Dasatinib 140 mg QD | 44.2 | Not reported | 35.5 | 52.5 | Not reported |
| Dasatinib 50 mg BID | 58.7 | Not reported | 49.8 | 66.5 | Not reported |
| Dasatinib 70 mg BID | 52.5 | Not reported | 43.7 | 60.5 | Not reported |
72 Months (n=167, 167, 168, 168)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 100 mg QD | 40.0 | Not reported | 39.2 | 56.2 | Not reported |
| Dasatinib 140 mg QD | 39.2 | Not reported | 30.6 | 47.7 | Not reported |
| Dasatinib 50 mg BID | 52.8 | Not reported | 43.7 | 61.1 | Not reported |
| Dasatinib 70 mg BID | 47.7 | Not reported | 38.7 | 56.0 | Not reported |
84 Months (n=167, 167, 168, 168)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 100 mg QD | 42.1 | Not reported | 33.4 | 50.6 | Not reported |
| Dasatinib 140 mg QD | 38.2 | Not reported | 29.6 | 46.7 | Not reported |
| Dasatinib 50 mg BID | 43.9 | Not reported | 34.5 | 52.9 | Not reported |
| Dasatinib 70 mg BID | 43.5 | Not reported | 34.5 | 52.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 69.9
- upper Limit
- 83.2
- value
- 77.4
- group Id
- OG001
- lower Limit
- 59.6
- upper Limit
- 74.5
- value
- 67.7
- group Id
- OG002
- lower Limit
- 64.3
- upper Limit
- 78.7
- value
- 72.2
- group Id
- OG003
- lower Limit
- 66.1
- upper Limit
- 80.1
- value
- 73.9
- title
- 24 Months (n=167, 167, 168, 168)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 58.3
- upper Limit
- 73.6
- value
- 66.6
- group Id
- OG001
- lower Limit
- 45.4
- upper Limit
- 61.8
- value
- 54.0
- group Id
- OG002
- lower Limit
- 59.2
- upper Limit
- 74.5
- value
- 67.5
- group Id
- OG003
- lower Limit
- 54.3
- upper Limit
- 70.1
- value
- 62.8
- title
- 36 Months (n=167, 167, 168, 168)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.6
- upper Limit
- 66.6
- value
- 59.1
- group Id
- OG001
- lower Limit
- 39.4
- upper Limit
- 56.2
- value
- 48.0
- group Id
- OG002
- lower Limit
- 54.8
- upper Limit
- 70.7
- value
- 63.3
- group Id
- OG003
- lower Limit
- 50.1
- upper Limit
- 66.3
- value
- 58.7
- title
- 48 Months (n=167, 167, 168, 168)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.8
- upper Limit
- 60.5
- value
- 52.5
- group Id
- OG001
- lower Limit
- 35.5
- upper Limit
- 52.5
- value
- 44.2
- group Id
- OG002
- lower Limit
- 49.8
- upper Limit
- 66.5
- value
- 58.7
- group Id
- OG003
- lower Limit
- 43.7
- upper Limit
- 60.5
- value
- 52.5
- title
- 60 Months (n=167, 167, 168, 168)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 39.2
- upper Limit
- 56.2
- value
- 40.0
- group Id
- OG001
- lower Limit
- 30.6
- upper Limit
- 47.7
- value
- 39.2
- group Id
- OG002
- lower Limit
- 43.7
- upper Limit
- 61.1
- value
- 52.8
- group Id
- OG003
- lower Limit
- 38.7
- upper Limit
- 56.0
- value
- 47.7
- title
- 72 Months (n=167, 167, 168, 168)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33.4
- upper Limit
- 50.6
- value
- 42.1
- group Id
- OG001
- lower Limit
- 29.6
- upper Limit
- 46.7
- value
- 38.2
- group Id
- OG002
- lower Limit
- 34.5
- upper Limit
- 52.9
- value
- 43.9
- group Id
- OG003
- lower Limit
- 34.5
- upper Limit
- 52.1
- value
- 43.5
- title
- 84 Months (n=167, 167, 168, 168)
- denoms
- counts
- group Id
- OG000
- value
- 167
- group Id
- OG001
- value
- 167
- group Id
- OG002
- value
- 168
- group Id
- OG003
- value
- 168
- units
- Participants
- description
- PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to \> 20,000/mm\^3 or an increase by \> 50,000/mm\^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- id
- OG000
- title
- Dasatinib 100 mg QD
- description
- Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- id
- OG001
- title
- Dasatinib 140 mg QD
- description
- Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- id
- OG002
- title
- Dasatinib 50 mg BID
- description
- Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- id
- OG003
- title
- Dasatinib 70 mg BID
- param Type
- NUMBER
- population Description
- All participants who were randomized to a treatment arm were summarized.
- reporting Status
- POSTED
- time Frame
- 24, 36, 48, 60, 72, and 84 months
- title
- Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice