Trial Outcomes & Findings for Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM) (NCT NCT00290771)
NCT ID: NCT00290771
Last Updated: 2011-05-16
Results Overview
Patients with an OOR were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed with magnetic resonance imaging. A patient had a CR if the target tumors disappeared. A patient had a PR if there was a ≥ 50% reduction in the sum of the products of the largest perpendicular diameters of the target tumors compared to the baseline value. A best response of CR required at least 2 determinations of CR at least 4 weeks apart. A best response of PR required at least 2 determinations of PR or better at least 4 weeks apart (and not qualifying for CR).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
231 participants
Primary outcome timeframe
Baseline to end of study (Month 24)
Results posted on
2011-05-16
Participant Flow
Participant milestones
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
100
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
127
|
97
|
Reasons for withdrawal
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
|---|---|---|
|
Overall Study
Disease progression
|
95
|
73
|
|
Overall Study
Death
|
11
|
10
|
|
Overall Study
Adverse Event
|
12
|
6
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Administrative problems
|
2
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)
Baseline characteristics by cohort
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
n=131 Participants
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
n=100 Participants
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
53.7 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (Month 24)Population: Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.
Patients with an OOR were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed with magnetic resonance imaging. A patient had a CR if the target tumors disappeared. A patient had a PR if there was a ≥ 50% reduction in the sum of the products of the largest perpendicular diameters of the target tumors compared to the baseline value. A best response of CR required at least 2 determinations of CR at least 4 weeks apart. A best response of PR required at least 2 determinations of PR or better at least 4 weeks apart (and not qualifying for CR).
Outcome measures
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
n=131 Participants
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
n=100 Participants
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg
n=231 Participants
Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
|
|---|---|---|---|
|
Percentage of Patients With an Objective Overall Response (OOR)
|
3.8 Percentage of participants
Interval 1.3 to 8.7
|
3.0 Percentage of participants
Interval 0.6 to 8.5
|
3.5 Percentage of participants
Interval 1.5 to 6.7
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 24)Population: Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.
Duration of OOR only included patients whose best overall response was complete response (CR) or partial response (PR). The start date was the date of the first documented response (CR or PR); the end date was the date of the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, the duration of OOR was censored at the time of the last OOR assessment.
Outcome measures
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
n=131 Participants
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
n=100 Participants
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg
n=231 Participants
Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
|
|---|---|---|---|
|
Duration of Objective Overall Response (OOR)
|
41.1 Weeks
Interval 32.1 to 53.6
|
32.1 Weeks
Interval 20.1 to
The upper bound of the confidence interval was non-estimable.
|
37.1 Weeks
Interval 32.1 to 53.6
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 24)Population: Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.
Patients who had clinical benefit were patients with a best response of complete response (CR), partial response (PR), or stable disease (SD) lasting for more than 6 months from the start of treatment until the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. SD was defined as insufficient tumor shrinkage to qualify for PR or CR and no increase in lesions which would qualify as PD.
Outcome measures
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
n=131 Participants
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
n=100 Participants
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg
n=231 Participants
Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
|
|---|---|---|---|
|
Percentage of Patients Who Had Clinical Benefit
|
9.9 Percentage of participants
Interval 5.4 to 16.4
|
6.0 Percentage of participants
Interval 2.2 to 12.6
|
8.2 Percentage of participants
Interval 5.0 to 12.5
|
SECONDARY outcome
Timeframe: Months 6 and 12Population: Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.
Progression-free survival (PFS) was defined as the time from the start of treatment to the date of the first documented disease progression (PD) or death due to any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, progression-free survival was censored at the time of the last overall response assessment.
Outcome measures
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
n=131 Participants
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
n=100 Participants
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg
n=231 Participants
Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
|
|---|---|---|---|
|
Percentage of Patients With Progression-free Survival at Months 6 and 12
6 Months
|
11.2 Percentage of participants
Interval 5.7 to 16.6
|
9.9 Percentage of participants
Interval 3.8 to 15.9
|
10.6 Percentage of participants
Interval 6.5 to 14.7
|
|
Percentage of Patients With Progression-free Survival at Months 6 and 12
12 Months
|
6.9 Percentage of participants
Interval 2.4 to 11.3
|
3.3 Percentage of participants
Interval 0.0 to 6.9
|
5.3 Percentage of participants
Interval 2.3 to 8.3
|
SECONDARY outcome
Timeframe: Months 6, 12, and 24Population: Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.
Patients not known to have died were censored at the time of last survival follow-up.
Outcome measures
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
n=131 Participants
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
n=100 Participants
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg
n=231 Participants
Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
|
|---|---|---|---|
|
Percentage of Patients Surviving at Months 6, 12, and 24
6 Months
|
49.2 Percentage of participants
Interval 40.7 to 57.8
|
50.9 Percentage of participants
Interval 40.9 to 61.0
|
50.0 Percentage of participants
Interval 43.4 to 56.5
|
|
Percentage of Patients Surviving at Months 6, 12, and 24
12 Months
|
28.5 Percentage of participants
Interval 20.7 to 36.2
|
31.3 Percentage of participants
Interval 21.9 to 40.7
|
29.7 Percentage of participants
Interval 23.7 to 35.7
|
|
Percentage of Patients Surviving at Months 6, 12, and 24
24 Months
|
10.7 Percentage of participants
Interval 3.3 to 18.1
|
20.3 Percentage of participants
Interval 11.8 to 28.9
|
13.9 Percentage of participants
Interval 8.0 to 19.7
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 24)Population: Safety population: All patients who received at least 1 dose of either of the 2 study drugs and who had at least 1 post-baseline safety assessment.
An adverse event (AE) is any undesirable sign, symptom, or medical condition occurring after starting study drug even if the event is not considered to be related to study drug. Study drug refers to imatinib or hydroxyurea. The study treatment is the combination of these two study drugs.
Outcome measures
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
n=131 Participants
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
n=100 Participants
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg
n=231 Participants
Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
|
|---|---|---|---|
|
Number of Patients With at Least 1 Adverse Event
|
129 Participants
|
98 Participants
|
227 Participants
|
Adverse Events
Imatinib 600 mg + Hydroxyurea 1000 mg
Serious events: 62 serious events
Other events: 122 other events
Deaths: 0 deaths
Imatinib 1000 mg + Hydroxyurea 1000 mg
Serious events: 53 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
n=131 participants at risk
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
n=99 participants at risk
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
|---|---|---|
|
Nervous system disorders
Depressed level of consciousness
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
3.0%
3/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Headache
|
3.1%
4/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
4.0%
4/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Hemiparesis
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
3.0%
3/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Hemiplegia
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
2.0%
2/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Hypokinesia
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Hypotonia
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Intracranial pressure increased
|
3.1%
4/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
4.0%
4/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Neurological decompensation
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Partial seizures
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Sciatica
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Somnolence
|
2.3%
3/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Tongue biting
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
4.0%
4/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Disorientation
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Personality change due to a general medical condition
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Staring
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Stress
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Renal and urinary disorders
Incontinence
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Renal and urinary disorders
Urinary retention
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.1%
4/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
5.1%
5/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
2.0%
2/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Vascular disorders
Hypotension
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
2.0%
2/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.6%
6/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
2.0%
2/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Cardiac disorders
Tachycardia
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Eye disorders
Amaurosis
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Eye disorders
Diplopia
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
2.0%
2/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Nausea
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
4.0%
4/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Palatal oedema
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Peritonitis
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
5.1%
5/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Asthenia
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Chest pain
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Fatigue
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Gait disturbance
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
General physical health deterioration
|
7.6%
10/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
3.0%
3/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Oedema
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Oedema peripheral
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Pyrexia
|
3.8%
5/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
2.0%
2/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Sudden death
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Cystitis
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Herpes zoster
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Infection
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Lung infection
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Pneumonia
|
5.3%
7/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Sepsis
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Septic embolus
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Septic shock
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Urosepsis
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
3/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Investigations
Blood amylase increased
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Investigations
Lipase increased
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Investigations
Oxygen saturation decreased
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
6.9%
9/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
12.1%
12/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Aphasia
|
1.5%
2/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
2.0%
2/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Ataxia
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Brain oedema
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
2.0%
2/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Cerebral cyst
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Cognitive disorder
|
0.76%
1/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
0.00%
0/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Convulsion
|
4.6%
6/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
5.1%
5/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
Other adverse events
| Measure |
Imatinib 600 mg + Hydroxyurea 1000 mg
n=131 participants at risk
Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
Imatinib 1000 mg + Hydroxyurea 1000 mg
n=99 participants at risk
Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.5%
19/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
10.1%
10/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.1%
8/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
9.1%
9/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.3%
3/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
7.1%
7/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.5%
15/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
6.1%
6/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.5%
19/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
10.1%
10/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Endocrine disorders
Cushingoid
|
3.8%
5/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
8.1%
8/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Eye disorders
Eyelid oedema
|
13.0%
17/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
8.1%
8/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Eye disorders
Vision blurred
|
6.1%
8/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
5.1%
5/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Constipation
|
16.8%
22/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
9.1%
9/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.6%
27/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
16.2%
16/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Nausea
|
37.4%
49/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
37.4%
37/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Gastrointestinal disorders
Vomiting
|
30.5%
40/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
22.2%
22/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Asthenia
|
11.5%
15/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
13.1%
13/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Face oedema
|
5.3%
7/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
6.1%
6/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Fatigue
|
30.5%
40/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
37.4%
37/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
General physical health deterioration
|
6.1%
8/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
7.1%
7/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Oedema
|
9.2%
12/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Oedema peripheral
|
23.7%
31/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
24.2%
24/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Pain
|
5.3%
7/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
General disorders
Pyrexia
|
5.3%
7/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
7.1%
7/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
10/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
8.1%
8/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Oral candidiasis
|
4.6%
6/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
6.1%
6/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
8/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
4.0%
4/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.6%
10/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
11.1%
11/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
7/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
1.0%
1/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
8/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
2.0%
2/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.4%
11/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
7.1%
7/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Amnesia
|
5.3%
7/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
8.1%
8/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Aphasia
|
3.1%
4/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
7.1%
7/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Ataxia
|
8.4%
11/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
11.1%
11/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
5.1%
5/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Cognitive disorder
|
7.6%
10/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
13.1%
13/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Convulsion
|
5.3%
7/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
2.0%
2/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Dizziness
|
9.9%
13/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
15.2%
15/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Epilepsy
|
3.8%
5/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
5.1%
5/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Headache
|
25.2%
33/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
20.2%
20/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Hemiparesis
|
4.6%
6/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
7.1%
7/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
11.5%
15/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
11.1%
11/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.1%
8/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
6.1%
6/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Somnolence
|
9.2%
12/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
7.1%
7/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Speech disorder
|
6.1%
8/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
8.1%
8/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Nervous system disorders
Tremor
|
7.6%
10/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
7.1%
7/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Confusional state
|
12.2%
16/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
11.1%
11/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Insomnia
|
11.5%
15/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
9.1%
9/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Psychiatric disorders
Mood altered
|
6.1%
8/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
6.1%
6/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Renal and urinary disorders
Incontinence
|
3.1%
4/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
5.1%
5/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
5.3%
7/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
7.1%
7/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
8/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
4.0%
4/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.9%
9/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
8.1%
8/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
7.6%
10/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
7.1%
7/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.7%
14/131
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
13.1%
13/99
The analysis was done on the safety population which consisted of 131 patients in the imatinib 600 mg plus hydroxyurea 1000 mg group and 99 patients in the imatinib 1000 mg plus hydroxyurea 1000 mg group.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER