Trial Outcomes & Findings for A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia (NCT NCT03589326)
NCT ID: NCT03589326
Last Updated: 2025-11-26
Results Overview
MRD-negative CR was achieved when a participant met the criteria for both MRD negativity and CR. MRD-negativity: ≤0.01 % breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (cDNA) with ≥ 10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (\<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system \[CNS\] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) \> 1000 per microliter (/mcL) (or \>1.0\*10\^9/L). 5. Platelets \>100,000/mcL (or \>100\*10\^9/L).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
245 participants
Primary outcome timeframe
From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days)
Results posted on
2025-11-26
Participant Flow
Participants took part in the study at 77 investigative sites in Australia, China, Korea, Taiwan, Austria, France, Greece, Italy, Poland, Russia, Spain, Turkey, United States, Canada, Mexico, Argentina and Brazil from 04 October 2018 to 31 July 2027. This study is ongoing. The data is reported for primary outcome measures up to 12 August 2022.
Participants with a diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) were enrolled in a 2:1 ratio to receive ponatinib or imatinib.
Participant milestones
| Measure |
Cohort A: Ponatinib 30 mg
Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\<60 years \[yrs\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\^2 as 2-hour IV infusion (\<60 yrs) and 250 mg/m\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022.
|
Cohort B: Imatinib 600 mg
Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\^2 every 12 hours as a 2-hour-IV infusion (\<60 yrs) and 250 mg/m\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.
|
|---|---|---|
|
IP (Cycles 1-3) (Cycle Length=28 Days)
STARTED
|
164
|
81
|
|
IP (Cycles 1-3) (Cycle Length=28 Days)
Efficacy Evaluable Population
|
154
|
78
|
|
IP (Cycles 1-3) (Cycle Length=28 Days)
Safety Population
|
163
|
81
|
|
IP (Cycles 1-3) (Cycle Length=28 Days)
COMPLETED
|
0
|
0
|
|
IP (Cycles 1-3) (Cycle Length=28 Days)
NOT COMPLETED
|
164
|
81
|
|
CP (Cycles 4-9) (Cycle Length=28 Days)
STARTED
|
0
|
0
|
|
CP (Cycles 4-9) (Cycle Length=28 Days)
COMPLETED
|
0
|
0
|
|
CP (Cycles 4-9) (Cycle Length=28 Days)
NOT COMPLETED
|
0
|
0
|
|
MP (Cycles 10-20) (Cycle Length=28 Days)
STARTED
|
0
|
0
|
|
MP (Cycles 10-20) (Cycle Length=28 Days)
COMPLETED
|
0
|
0
|
|
MP (Cycles 10-20) (Cycle Length=28 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: Ponatinib 30 mg
Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\<60 years \[yrs\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\^2 as 2-hour IV infusion (\<60 yrs) and 250 mg/m\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022.
|
Cohort B: Imatinib 600 mg
Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\^2 every 12 hours as a 2-hour-IV infusion (\<60 yrs) and 250 mg/m\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.
|
|---|---|---|
|
IP (Cycles 1-3) (Cycle Length=28 Days)
Participants Ongoing on Study
|
135
|
63
|
|
IP (Cycles 1-3) (Cycle Length=28 Days)
Death
|
21
|
13
|
|
IP (Cycles 1-3) (Cycle Length=28 Days)
Lost to Follow-up
|
0
|
1
|
|
IP (Cycles 1-3) (Cycle Length=28 Days)
Withdrawal by Subject
|
6
|
4
|
|
IP (Cycles 1-3) (Cycle Length=28 Days)
Reason not Specified
|
2
|
0
|
Baseline Characteristics
Number analyzed are the number of participants available for height at baseline.
Baseline characteristics by cohort
| Measure |
Cohort A: Ponatinib 30 mg
n=164 Participants
Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\<60 years \[yrs\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\^2 as 2-hour IV infusion (\<60 yrs) and 250 mg/m\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022.
|
Cohort B: Imatinib 600 mg
n=81 Participants
Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\^2 every 12 hours as a 2-hour-IV infusion (\<60 yrs) and 250 mg/m\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
90 Participants
n=164 Participants
|
43 Participants
n=81 Participants
|
133 Participants
n=245 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 16.09 • n=164 Participants
|
50.6 years
STANDARD_DEVIATION 14.60 • n=81 Participants
|
51.0 years
STANDARD_DEVIATION 15.59 • n=245 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=164 Participants
|
38 Participants
n=81 Participants
|
112 Participants
n=245 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=164 Participants
|
2 Participants
n=81 Participants
|
4 Participants
n=245 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=164 Participants
|
11 Participants
n=81 Participants
|
31 Participants
n=245 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=164 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=245 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=164 Participants
|
4 Participants
n=81 Participants
|
13 Participants
n=245 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=164 Participants
|
62 Participants
n=81 Participants
|
166 Participants
n=245 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=164 Participants
|
0 Participants
n=81 Participants
|
1 Participants
n=245 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=164 Participants
|
2 Participants
n=81 Participants
|
30 Participants
n=245 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
39 Participants
n=164 Participants
|
20 Participants
n=81 Participants
|
59 Participants
n=245 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic and Latino
|
105 Participants
n=164 Participants
|
56 Participants
n=81 Participants
|
161 Participants
n=245 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
15 Participants
n=164 Participants
|
4 Participants
n=81 Participants
|
19 Participants
n=245 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 Participants
n=164 Participants
|
1 Participants
n=81 Participants
|
6 Participants
n=245 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=164 Participants
|
2 Participants
n=81 Participants
|
6 Participants
n=245 Participants
|
|
Region of Enrollment
China
|
14 Participants
n=164 Participants
|
8 Participants
n=81 Participants
|
22 Participants
n=245 Participants
|
|
Region of Enrollment
Korea, South
|
1 Participants
n=164 Participants
|
2 Participants
n=81 Participants
|
3 Participants
n=245 Participants
|
|
Region of Enrollment
Taiwan
|
3 Participants
n=164 Participants
|
0 Participants
n=81 Participants
|
3 Participants
n=245 Participants
|
|
Region of Enrollment
Austria
|
3 Participants
n=164 Participants
|
3 Participants
n=81 Participants
|
6 Participants
n=245 Participants
|
|
Region of Enrollment
France
|
9 Participants
n=164 Participants
|
1 Participants
n=81 Participants
|
10 Participants
n=245 Participants
|
|
Region of Enrollment
Greece
|
4 Participants
n=164 Participants
|
1 Participants
n=81 Participants
|
5 Participants
n=245 Participants
|
|
Region of Enrollment
Italy
|
28 Participants
n=164 Participants
|
10 Participants
n=81 Participants
|
38 Participants
n=245 Participants
|
|
Region of Enrollment
Poland
|
5 Participants
n=164 Participants
|
2 Participants
n=81 Participants
|
7 Participants
n=245 Participants
|
|
Region of Enrollment
Russia
|
5 Participants
n=164 Participants
|
6 Participants
n=81 Participants
|
11 Participants
n=245 Participants
|
|
Region of Enrollment
Spain
|
16 Participants
n=164 Participants
|
9 Participants
n=81 Participants
|
25 Participants
n=245 Participants
|
|
Region of Enrollment
Turkey
|
1 Participants
n=164 Participants
|
1 Participants
n=81 Participants
|
2 Participants
n=245 Participants
|
|
Region of Enrollment
Canada
|
8 Participants
n=164 Participants
|
5 Participants
n=81 Participants
|
13 Participants
n=245 Participants
|
|
Region of Enrollment
Mexico
|
2 Participants
n=164 Participants
|
1 Participants
n=81 Participants
|
3 Participants
n=245 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=164 Participants
|
20 Participants
n=81 Participants
|
60 Participants
n=245 Participants
|
|
Region of Enrollment
Argentina
|
3 Participants
n=164 Participants
|
0 Participants
n=81 Participants
|
3 Participants
n=245 Participants
|
|
Region of Enrollment
Brazil
|
18 Participants
n=164 Participants
|
10 Participants
n=81 Participants
|
28 Participants
n=245 Participants
|
|
Height
|
167.24 centimeters (cm)
STANDARD_DEVIATION 9.980 • n=158 Participants • Number analyzed are the number of participants available for height at baseline.
|
167.27 centimeters (cm)
STANDARD_DEVIATION 9.029 • n=76 Participants • Number analyzed are the number of participants available for height at baseline.
|
167.25 centimeters (cm)
STANDARD_DEVIATION 9.662 • n=234 Participants • Number analyzed are the number of participants available for height at baseline.
|
|
Weight
|
74.17 kilograms (kg)
STANDARD_DEVIATION 18.675 • n=163 Participants • Number analyzed are the number of participants available for weight at baseline.
|
76.23 kilograms (kg)
STANDARD_DEVIATION 18.565 • n=81 Participants • Number analyzed are the number of participants available for weight at baseline.
|
74.86 kilograms (kg)
STANDARD_DEVIATION 18.626 • n=244 Participants • Number analyzed are the number of participants available for weight at baseline.
|
|
Body Surface Area (BSA)
|
1.84 meters squared (m^2)
STANDARD_DEVIATION 0.261 • n=157 Participants • Number analyzed are the number of participants available for BSA at baseline.
|
1.86 meters squared (m^2)
STANDARD_DEVIATION 0.255 • n=76 Participants • Number analyzed are the number of participants available for BSA at baseline.
|
1.85 meters squared (m^2)
STANDARD_DEVIATION 0.258 • n=233 Participants • Number analyzed are the number of participants available for BSA at baseline.
|
PRIMARY outcome
Timeframe: From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days)Population: ITT population with p190/p210 variant was defined as all participants in the ITT population who were identified by the central laboratory as having baseline breakpoint cluster region-Abelson1 (BCR-ABL1) dominant variants of p190 or p210.
MRD-negative CR was achieved when a participant met the criteria for both MRD negativity and CR. MRD-negativity: ≤0.01 % breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (cDNA) with ≥ 10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (\<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system \[CNS\] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) \> 1000 per microliter (/mcL) (or \>1.0\*10\^9/L). 5. Platelets \>100,000/mcL (or \>100\*10\^9/L).
Outcome measures
| Measure |
Cohort A: Ponatinib 30 mg
n=154 Participants
Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\<60 years \[yrs\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\^2 as 2-hour IV infusion (\<60 yrs) and 250 mg/m\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022.
|
Cohort B: Imatinib 600 mg
n=78 Participants
Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\^2 every 12 hours as a 2-hour-IV infusion (\<60 yrs) and 250 mg/m\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.
|
|---|---|---|
|
Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase
|
53 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 3 to 6 yearsEFS is defined as the dates of randomization until death due to any cause or failure to achieve CR by end of induction or relapse from CR. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (\<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system \[CNS\] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) greater than (\>) 1000 per micro liter (/mcL) (or \>1.0\*10\^9/L). 5. Platelets \>100,000/mcL (or \>100\*10\^9/L).Relapse from CR: reappearance of blasts in the blood or BM (\>=5%) or in any extramedullary site after a CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of Cycle 1 (approximately 1 month), Cycle 2 (approximately 2 months), Cycle 3 (approximately 3 months), and Cycle 9 (approximately 9 months) (Cycle length= 28 days)CR is defined as meeting all the following for at least 4 weeks (that is, no recurrence): 1. No circulating blasts and \<5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC \>1000/mcL (or \>1.0\*10\^9/L). 5. Platelets \>100,000/mcL (or \>100\*10\^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of Cycle 1 (approximately 1 month), Cycle 2 (approximately 2 months), Cycle 3 (approximately 3 months), and Cycle 9 (approximately 9 months) (Cycle length= 28 days)Molecule response is assessed by 3-Log Reduction (MR3), Molecular Response 4-Log Reduction (MR4) and Molecular Response 4.5-Log Reduction (MR4.5). MR3 is defined as molecular response 3-log reduction (\<=0.1% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with \>=1000 ABL1 transcripts. MR4 is defined as molecular response 4-log reduction (\<=0.01% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with \>=10,000 ABL1 transcripts. MR4.5 is defined as Molecular response 4.5-log reduction (\<=0.0032% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with \>=32,000 ABL1 transcripts.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsPIF is defined as participants who received treatment for ALL but never achieved CR or CRi by the end of induction. PIF is not limited by the number of unsuccessful treatments; this disease status only applies to recipients who have never been in CR or CRi. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and \<5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC \>1000/mcL (or \>1.0\*10\^9/L). 5. Platelets \>100,000/mcL (or \>100\*10\^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsORR is defined as CR + CRi by end of induction. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and \<5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC \>1000/mcL (or \>1.0\*10\^9/L). 5. Platelets \>100,000/mcL (or \>100\*10\^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 3 to 6 yearsMRD is defined as the percentage of participants achieving CR who are MRD-negative at multiple intervals after end of induction. MRD negativity: \<=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with \>=10,000 ABL1 transcripts. Relapse from CR: Reappearance of blasts in the blood or BM (\>=5%) or in any extramedullary site after a CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 3 to 6 yearsDuration of MRD-negative CR is defined as interval between the first assessment at which the criteria for MRD-negative CR are met until the earliest date at which loss of MRD negativity or relapse from CR occurs. MRD negativity (MR4): \<=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with \>=10,000 ABL1 transcripts. CR is defined as meeting all the following for at least 4 weeks (that is, no recurrence): 1. No circulating blasts and \<5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC \>1000/mcL (or \>1.0\*10\^9/L). 5. Platelets \>100,000/mcL (or \>100\*10\^9/L). Relapse from CR: Reappearance of blasts in the blood or BM (\>=5%) or in any extramedullary site after a CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 3 to 6 yearsDuration of CR is defined as interval between the first assessment at which the criteria for CR are met until the earliest date at which relapse from CR occurs. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and \<5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC \>1000/mcL (or \>1.0\*10\^9/L). 5. Platelets \>100,000/mcL (or \>100\*10\^9/L). Relapse from CR: Reappearance of blasts in the blood or BM (\>=5%) or in any extramedullary site after a CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 yearsTime to treatment failure is defined as time to end of study randomized treatment (except for hematopoietic stem cell transplantation \[HSCT\] without loss of MRD-negative CR) due to safety and efficacy reasons. MRD-negative CR is achieved when a participant meets the criteria for both MRD negativity and CR. MRD-negativity: \<=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with \>=10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and \<5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC \>1000/mcL (or \>1.0\*10\^9/L). 5. Platelets \>100,000/mcL (or \>100\*10\^9/L).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 3 to 6 yearsDuration of MR4.5 is defined as interval between the first assessment at which the criteria for MR4.5 are met until the earliest date at which loss of MR4.5 occurs. MR4.5 is molecular response 4.5-log reduction (\<=0.0032% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with \>=32,000 ABL1 transcripts.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 3 to 6 yearsOn-study participants with or without HSCT will be evaluated. OS is defined as interval between randomization and death due to any cause, censored at the last contact date when the participant was alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 3 to 6 yearsOn-study participants with or without HSCT will be evaluated. Relapse from CR is defined as reappearance of blasts in the blood or BM (\>=5%) or in any extramedullary site after a CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 3 to 6 yearsOS is defined as interval between the randomization and death due to any cause, censored at the last contact date when the participant was alive.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A: Ponatinib 30 mg
Serious events: 97 serious events
Other events: 159 other events
Deaths: 21 deaths
Cohort B: Imatinib 600 mg
Serious events: 45 serious events
Other events: 80 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Cohort A: Ponatinib 30 mg
n=163 participants at risk
Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\<60 years \[yrs\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\^2 as 2-hour IV infusion (\<60 yrs) and 250 mg/m\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022.
|
Cohort B: Imatinib 600 mg
n=81 participants at risk
Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\^2 every 12 hours as a 2-hour-IV infusion (\<60 yrs) and 250 mg/m\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
4.3%
7/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Sepsis
|
3.7%
6/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Pneumonia
|
2.5%
4/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
3.7%
3/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Septic shock
|
3.7%
6/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
3.7%
3/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.8%
3/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Cellulitis
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Device related infection
|
1.8%
3/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
3/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Bacteraemia
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Klebsiella sepsis
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Vascular device infection
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Abdominal sepsis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Aspergillus infection
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Catheter site infection
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Clostridium colitis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Diverticulitis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Enterobacter infection
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Infection
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Meningitis bacterial
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Mucormycosis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Neutropenic infection
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Pseudomonas infection
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
SARS-CoV-2 viraemia
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Skin infection
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Stenotrophomonas bacteraemia
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Tonsillitis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.6%
27/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
14.8%
12/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
6/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
4/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
4/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.5%
4/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Anal fissure
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Headache
|
1.8%
3/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Migraine
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Myelitis transverse
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Polyneuropathy
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Pyrexia
|
3.7%
6/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
3.7%
3/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Asthenia
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Chest pain
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Drug withdrawal syndrome
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Platelet count decreased
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Neutrophil count decreased
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Ejection fraction decreased
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Haemoglobin decreased
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
White blood cell count decreased
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
pH urine decreased
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
3/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Vascular disorders
Brachiocephalic vein thrombosis
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Vascular disorders
Hypotension
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Psychiatric disorders
Major depression
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Psychiatric disorders
Psychomotor retardation
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Immune system disorders
Immunisation reaction
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
0.00%
0/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
Other adverse events
| Measure |
Cohort A: Ponatinib 30 mg
n=163 participants at risk
Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\<60 years \[yrs\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\^2 as 2-hour IV infusion (\<60 yrs) and 250 mg/m\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022.
|
Cohort B: Imatinib 600 mg
n=81 participants at risk
Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\^2 every 12 hours as a 2-hour-IV infusion (\<60 yrs) and 250 mg/m\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
41.1%
67/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
33.3%
27/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Lipase increased
|
27.0%
44/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
35.8%
29/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Platelet count decreased
|
23.9%
39/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
32.1%
26/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Neutrophil count decreased
|
20.9%
34/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
32.1%
26/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
23.9%
39/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
18.5%
15/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
White blood cell count decreased
|
15.3%
25/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
24.7%
20/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.9%
21/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
9.9%
8/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.7%
19/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
9.9%
8/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Amylase increased
|
9.8%
16/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
12.3%
10/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.6%
14/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
8.6%
7/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Blood creatinine increased
|
6.1%
10/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
9.9%
8/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Blood bilirubin increased
|
8.6%
14/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
3.7%
3/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Blood fibrinogen decreased
|
5.5%
9/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
6.2%
5/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
C-reactive protein increased
|
4.9%
8/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
6.2%
5/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Lymphocyte count decreased
|
3.1%
5/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
9.9%
8/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Weight decreased
|
4.3%
7/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
7.4%
6/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Investigations
Transaminases increased
|
6.1%
10/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
35.0%
57/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
49.4%
40/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Constipation
|
38.0%
62/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
21.0%
17/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
22.1%
36/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
38.3%
31/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.2%
28/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
32.1%
26/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
19.0%
31/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
18.5%
15/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.3%
25/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
12.3%
10/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.1%
23/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
7.4%
6/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.6%
14/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
8.6%
7/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.2%
15/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
4.9%
4/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Toothache
|
6.1%
10/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
3.7%
3/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.5%
9/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
3.7%
3/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
43.6%
71/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
54.3%
44/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
46.0%
75/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
38.3%
31/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
70/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
37.0%
30/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.1%
23/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
14.8%
12/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.0%
18/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
8.6%
7/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.8%
16/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
4.9%
4/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Headache
|
42.3%
69/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
43.2%
35/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
31.3%
51/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
23.5%
19/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Paraesthesia
|
20.2%
33/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
9.9%
8/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.0%
18/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
12.3%
10/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Dizziness
|
9.8%
16/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
12.3%
10/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
6.1%
10/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Nervous system disorders
Dysgeusia
|
1.8%
3/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
8.6%
7/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
24.5%
40/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
38.3%
31/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.0%
26/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
17.3%
14/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.5%
22/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
22.2%
18/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.4%
17/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
21.0%
17/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.2%
15/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
18.5%
15/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.8%
16/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
6.2%
5/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.4%
12/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
11.1%
9/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.1%
10/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
11.1%
9/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
7.4%
12/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
7.4%
6/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.9%
8/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
9.9%
8/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Pyrexia
|
35.0%
57/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
23.5%
19/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Fatigue
|
26.4%
43/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
22.2%
18/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Oedema peripheral
|
10.4%
17/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
32.1%
26/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Asthenia
|
16.0%
26/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
14.8%
12/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Pain
|
6.1%
10/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
4.9%
4/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Chest pain
|
6.7%
11/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
General disorders
Face oedema
|
1.8%
3/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
11.1%
9/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.4%
30/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
13.6%
11/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.2%
28/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
9.9%
8/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.4%
30/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
7.4%
6/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.3%
20/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
9.9%
8/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.6%
14/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
4.9%
4/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.5%
9/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
9.9%
8/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.4%
12/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
6.2%
5/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.5%
9/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
7.4%
6/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Vascular disorders
Hypertension
|
31.9%
52/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
13.6%
11/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Vascular disorders
Hypotension
|
6.1%
10/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
4.9%
4/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
4.9%
8/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
6.2%
5/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.0%
31/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
16.0%
13/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.8%
16/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
12/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.9%
8/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
6.2%
5/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.5%
9/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
COVID-19
|
12.9%
21/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
8.6%
7/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
13/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Conjunctivitis
|
7.4%
12/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Pneumonia
|
6.1%
10/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Infections and infestations
Folliculitis
|
5.5%
9/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
1.2%
1/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
21/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
4.9%
4/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
13/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
6.2%
5/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.6%
14/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
3.7%
3/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
7/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
6.2%
5/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.5%
9/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
2.5%
2/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.1%
10/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
0.00%
0/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Psychiatric disorders
Insomnia
|
19.0%
31/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
17.3%
14/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Psychiatric disorders
Anxiety
|
8.6%
14/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
8.6%
7/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Psychiatric disorders
Depression
|
5.5%
9/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
6.2%
5/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Eye disorders
Vision blurred
|
7.4%
12/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
3.7%
3/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Eye disorders
Periorbital oedema
|
0.61%
1/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
8.6%
7/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
|
Cardiac disorders
Tachycardia
|
6.7%
11/163 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
6.2%
5/81 • From signing of informed consent up to data cut-off date: 12 August 2022 (up to 46 months 1 week)
Safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER