TriangleNCT00123474 · OUTCOME
Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of 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, 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 randomized imatinib-intolerant participants with available data were summarized
Groups in this outcome
100mg QD
Participants received 100 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.
140mg 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.
50mg BID
Participants received 50 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.
70mg 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.
| Group | Source count |
|---|---|
| 100mg QD | 43 |
| 140mg QD | 44 |
| 50mg BID | 44 |
| 70mg BID | 42 |
Reported measurements
24 Months (n=43,44,44,42)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100mg QD | 83.6 | Not reported | 67.0 | 92.3 | Not reported |
| 140mg QD | 87.7 | Not reported | 72.8 | 94.7 | Not reported |
| 50mg BID | 77.4 | Not reported | 61.0 | 87.6 | Not reported |
| 70mg BID | 83.7 | Not reported | 67.1 | 92.4 | Not reported |
36 Months (n=43,44,44,42)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100mg QD | 71.7 | Not reported | 53.6 | 83.7 | Not reported |
| 140mg QD | 76.0 | Not reported | 58.7 | 86.8 | Not reported |
| 50mg BID | 68.6 | Not reported | 51.1 | 80.9 | Not reported |
| 70mg BID | 77.4 | Not reported | 59.6 | 88.1 | Not reported |
48 Months (n=43,44,44,42)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100mg QD | 62.7 | Not reported | 44.5 | 76.5 | Not reported |
| 140mg QD | 76.0 | Not reported | 58.7 | 86.8 | Not reported |
| 50mg BID | 62.0 | Not reported | 44.1 | 75.7 | Not reported |
| 70mg BID | 66.9 | Not reported | 47.8 | 80.4 | Not reported |
60 Months (n=43,44,44,42)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100mg QD | 59.2 | Not reported | 40.8 | 73.6 | Not reported |
| 140mg QD | 71.2 | Not reported | 52.1 | 83.8 | Not reported |
| 50mg BID | 62.0 | Not reported | 44.1 | 75.7 | Not reported |
| 70mg BID | 59.5 | Not reported | 40.1 | 74.4 | Not reported |
72 Months (n=43,44,44,42)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100mg QD | 59.2 | Not reported | 40.8 | 73.6 | Not reported |
| 140mg QD | 66.5 | Not reported | 46.3 | 80.6 | Not reported |
| 50mg BID | 58.2 | Not reported | 39.8 | 72.7 | Not reported |
| 70mg BID | 55.2 | Not reported | 35.7 | 71.1 | Not reported |
84 Months (n=43,44,44,42)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100mg QD | 50.9 | Not reported | 32.1 | 67.0 | Not reported |
| 140mg QD | 66.5 | Not reported | 46.3 | 80.6 | Not reported |
| 50mg BID | 47.5 | Not reported | 27.4 | 65.2 | Not reported |
| 70mg BID | 50.2 | Not reported | 30.4 | 67.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 67.0
- upper Limit
- 92.3
- value
- 83.6
- group Id
- OG001
- lower Limit
- 72.8
- upper Limit
- 94.7
- value
- 87.7
- group Id
- OG002
- lower Limit
- 61.0
- upper Limit
- 87.6
- value
- 77.4
- group Id
- OG003
- lower Limit
- 67.1
- upper Limit
- 92.4
- value
- 83.7
- title
- 24 Months (n=43,44,44,42)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 53.6
- upper Limit
- 83.7
- value
- 71.7
- group Id
- OG001
- lower Limit
- 58.7
- upper Limit
- 86.8
- value
- 76.0
- group Id
- OG002
- lower Limit
- 51.1
- upper Limit
- 80.9
- value
- 68.6
- group Id
- OG003
- lower Limit
- 59.6
- upper Limit
- 88.1
- value
- 77.4
- title
- 36 Months (n=43,44,44,42)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 44.5
- upper Limit
- 76.5
- value
- 62.7
- group Id
- OG001
- lower Limit
- 58.7
- upper Limit
- 86.8
- value
- 76.0
- group Id
- OG002
- lower Limit
- 44.1
- upper Limit
- 75.7
- value
- 62.0
- group Id
- OG003
- lower Limit
- 47.8
- upper Limit
- 80.4
- value
- 66.9
- title
- 48 Months (n=43,44,44,42)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 40.8
- upper Limit
- 73.6
- value
- 59.2
- group Id
- OG001
- lower Limit
- 52.1
- upper Limit
- 83.8
- value
- 71.2
- group Id
- OG002
- lower Limit
- 44.1
- upper Limit
- 75.7
- value
- 62.0
- group Id
- OG003
- lower Limit
- 40.1
- upper Limit
- 74.4
- value
- 59.5
- title
- 60 Months (n=43,44,44,42)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 40.8
- upper Limit
- 73.6
- value
- 59.2
- group Id
- OG001
- lower Limit
- 46.3
- upper Limit
- 80.6
- value
- 66.5
- group Id
- OG002
- lower Limit
- 39.8
- upper Limit
- 72.7
- value
- 58.2
- group Id
- OG003
- lower Limit
- 35.7
- upper Limit
- 71.1
- value
- 55.2
- title
- 72 Months (n=43,44,44,42)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.1
- upper Limit
- 67.0
- value
- 50.9
- group Id
- OG001
- lower Limit
- 46.3
- upper Limit
- 80.6
- value
- 66.5
- group Id
- OG002
- lower Limit
- 27.4
- upper Limit
- 65.2
- value
- 47.5
- group Id
- OG003
- lower Limit
- 30.4
- upper Limit
- 67.1
- value
- 50.2
- title
- 84 Months (n=43,44,44,42)
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 42
- 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 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
- 100mg 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.
- id
- OG001
- title
- 140mg QD
- description
- Participants received 50 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.
- id
- OG002
- title
- 50mg 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.
- id
- OG003
- title
- 70mg BID
- param Type
- NUMBER
- population Description
- All randomized imatinib-intolerant participants with available data were summarized
- reporting Status
- POSTED
- time Frame
- 24, 36, 48, 60, 72, and 84 months
- title
- Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice