Trial Outcomes & Findings for Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma (NCT NCT00154375)
NCT ID: NCT00154375
Last Updated: 2011-04-26
Results Overview
PFS was defined as the time from the date of randomization to the date of the first documented progression according to the MacDonald criteria, or death due to any cause. MacDonald criteria are standard criteria in neurooncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
6 months -1 year
Results posted on
2011-04-26
Participant Flow
Participant milestones
| Measure |
Imatinib Mesylate + Hydroxyurea (HU)
Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
|
Hydroxyurea Alone
1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
|
Overall Study
Discontinued Study Treatment
|
111
|
104
|
|
Overall Study
Not Exposed to Study Treatment
|
2
|
2
|
|
Overall Study
COMPLETED
|
7
|
14
|
|
Overall Study
NOT COMPLETED
|
113
|
106
|
Reasons for withdrawal
| Measure |
Imatinib Mesylate + Hydroxyurea (HU)
Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
|
Hydroxyurea Alone
1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
|
|---|---|---|
|
Overall Study
Unsatisfactory therapeutic effect
|
25
|
26
|
|
Overall Study
Adverse Event
|
18
|
20
|
|
Overall Study
Withdrawal by Subject
|
14
|
10
|
|
Overall Study
Death
|
5
|
13
|
|
Overall Study
Study drug no longer required
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Abnormal laboratory value(s)
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Suspected progression of disease
|
44
|
30
|
Baseline Characteristics
Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate + Hydroxyurea (HU)
n=120 Participants
Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
|
Hydroxyurea Alone
n=120 Participants
1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
52.1 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months -1 yearPopulation: The ITT population consists of all randomized patients, analyzed according to their randomized treatment.
PFS was defined as the time from the date of randomization to the date of the first documented progression according to the MacDonald criteria, or death due to any cause. MacDonald criteria are standard criteria in neurooncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).
Outcome measures
| Measure |
Imatinib Mesylate + Hydroxyurea (HU)
n=120 Participants
Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
|
Hydroxyurea Alone
n=120 Participants
1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
|
|---|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) During the Study Duration
6 months
|
5.3 Percentage of Participants
Interval 1.0 to 9.7
|
6.6 Percentage of Participants
Interval 2.1 to 11.1
|
|
Percentage of Participants With Progression Free Survival (PFS) During the Study Duration
12 months
|
2.1 Percentage of Participants
Interval 0.0 to 5.0
|
2.1 Percentage of Participants
Interval 0.0 to 5.5
|
SECONDARY outcome
Timeframe: 6 months - 1 yearPopulation: The safety population consisted of randomized patients with at least one dose of randomized medication.
National Cancer Institute (NCI)/ National Institute of Health (NIH) provides a grading (severity) scale for each AE term. Grade 3 refers to severe AE and Grade 4 refers to life-threatening or disabling AE. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.
Outcome measures
| Measure |
Imatinib Mesylate + Hydroxyurea (HU)
n=118 Participants
Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
|
Hydroxyurea Alone
n=118 Participants
1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
|
|---|---|---|
|
Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations
Deaths
|
84 Participants
|
91 Participants
|
|
Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations
Death due to disease progression
|
76 Participants
|
77 Participants
|
|
Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations
Serious Adverse Events (SAEs)
|
64 Participants
|
79 Participants
|
|
Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations
NCI/NIH Grade 3 (severe) or 4 (life threatening)
|
54 Participants
|
64 Participants
|
|
Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations
Suspected to be drug-related
|
12 Participants
|
12 Participants
|
|
Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations
Leading to dose adjustment or interruption
|
6 Participants
|
16 Participants
|
|
Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations
Leading to permanent discontinuation
|
9 Participants
|
13 Participants
|
Adverse Events
Imatinib Mesylate + Hydroxyurea (HU)
Serious events: 64 serious events
Other events: 104 other events
Deaths: 0 deaths
Period With Hydroxyurea Alone
Serious events: 46 serious events
Other events: 80 other events
Deaths: 0 deaths
Period After Switch to Combination
Serious events: 49 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib Mesylate + Hydroxyurea (HU)
n=118 participants at risk
Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Patients receiving a daily dose of 800 mg imatinib with 1000 mg HU were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
|
Period With Hydroxyurea Alone
n=118 participants at risk
1500 mg/day of HU given as 500 mg 3 times daily.
|
Period After Switch to Combination
n=85 participants at risk
After every 6 weeks from randomization, depending on the assessment of therapeutic effect, patients were switched from Hydroxyurea (1500 mg/day p.o) to combination arm where patients were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time).
|
|---|---|---|---|
|
Infections and infestations
SEPSIS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
PULMONARY SEPSIS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
VULVITIS
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Injury, poisoning and procedural complications
BRAIN CONTUSION
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Injury, poisoning and procedural complications
FALL
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.5%
3/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMORRHAGE
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Investigations
GENERAL PHYSICAL CONDITION ABNORMAL
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.9%
5/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Eye disorders
VISUAL DISTURBANCE
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
STOMATITIS
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
VOMITING
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
APLASIA
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
ASTHENIA
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
CHEST PAIN
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
DEATH
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
FATIGUE
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
5.9%
7/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
NECROSIS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
OEDEMA PERIPHERAL
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
PAIN
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
PYREXIA
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
ASPERGILLOSIS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
GASTROENTERITIS
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
INJECTION SITE ABSCESS
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
PNEUMONIA
|
7.6%
9/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.9%
5/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Infections and infestations
PNEUMONIA PRIMARY ATYPICAL
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTRACRANIAL TUMOUR HAEMORRHAGE
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM PROGRESSION
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
APHASIA
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
APRAXIA
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
CONVULSION
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.7%
4/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
COORDINATION ABNORMAL
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
DEMENTIA
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
DYSPHASIA
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
EPILEPSY
|
4.2%
5/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
7.6%
9/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
10.6%
9/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
HEADACHE
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.2%
5/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.5%
3/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
HEMIPARESIS
|
6.8%
8/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.2%
5/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
HEMIPLEGIA
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.7%
4/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
PARESIS
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
PARTIAL SEIZURES
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.7%
4/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
PSYCHOMOTOR SKILLS IMPAIRED
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
SOMNOLENCE
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
SPEECH DISORDER
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
ABNORMAL BEHAVIOUR
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
AGITATION
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
ANXIETY
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
HALLUCINATION
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
MENTAL DISORDER
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
PERSONALITY DISORDER
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Renal and urinary disorders
INCONTINENCE
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Renal and urinary disorders
OLIGURIA
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Renal and urinary disorders
RENAL COLIC
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Surgical and medical procedures
BRAIN LOBECTOMY
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Surgical and medical procedures
CYSTOSTOMY
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Surgical and medical procedures
TUMOUR EXCISION
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
Other adverse events
| Measure |
Imatinib Mesylate + Hydroxyurea (HU)
n=118 participants at risk
Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Patients receiving a daily dose of 800 mg imatinib with 1000 mg HU were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
|
Period With Hydroxyurea Alone
n=118 participants at risk
1500 mg/day of HU given as 500 mg 3 times daily.
|
Period After Switch to Combination
n=85 participants at risk
After every 6 weeks from randomization, depending on the assessment of therapeutic effect, patients were switched from Hydroxyurea (1500 mg/day p.o) to combination arm where patients were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
11.0%
13/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
6.8%
8/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
15.3%
13/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
13.6%
16/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
11.9%
14/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
16.5%
14/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
20.3%
24/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
12.7%
15/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
20.0%
17/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Endocrine disorders
CUSHINGOID
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.9%
5/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.9%
7/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
CONSTIPATION
|
9.3%
11/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.9%
5/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
DIARRHOEA
|
9.3%
11/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.7%
4/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
NAUSEA
|
23.7%
28/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
14.4%
17/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
11.8%
10/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Gastrointestinal disorders
VOMITING
|
17.8%
21/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
11.0%
13/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
7.1%
6/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
ASTHENIA
|
9.3%
11/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
10.6%
9/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
FATIGUE
|
28.8%
34/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
13.6%
16/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
21.2%
18/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
8.5%
10/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
6.8%
8/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.7%
4/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
OEDEMA PERIPHERAL
|
24.6%
29/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
10.2%
12/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
16.5%
14/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
General disorders
PYREXIA
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Injury, poisoning and procedural complications
FALL
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.9%
5/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Metabolism and nutrition disorders
ANOREXIA
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
11.9%
14/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
7.1%
6/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.7%
4/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
7.1%
6/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
11.0%
13/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.2%
5/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.5%
3/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
AMNESIA
|
6.8%
8/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.7%
4/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
APHASIA
|
7.6%
9/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.9%
5/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
CONVULSION
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
7.1%
6/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
COORDINATION ABNORMAL
|
7.6%
9/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
7.6%
9/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
7.1%
6/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
DIZZINESS
|
13.6%
16/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
8.2%
7/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
EPILEPSY
|
11.0%
13/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.5%
3/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
HEADACHE
|
22.0%
26/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
20.3%
24/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
18.8%
16/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
HEMIPARESIS
|
8.5%
10/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.9%
7/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
8.2%
7/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
LETHARGY
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.2%
5/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Nervous system disorders
SOMNOLENCE
|
5.9%
7/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.2%
1/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
7.6%
9/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.5%
3/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
DEPRESSION
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
7.1%
6/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
INSOMNIA
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.9%
5/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Psychiatric disorders
SLEEP DISORDER
|
5.1%
6/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
3.4%
4/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.4%
2/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.9%
7/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
2.5%
3/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
4.7%
4/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.8%
8/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
1.7%
2/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
|
Vascular disorders
THROMBOSIS
|
0.85%
1/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
0.00%
0/118
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
5.9%
5/85
Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)\[n=118\] or to Hydroxyurea alone \[n=118\]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone \[n=118\] or switch to combination \[n=85\].
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER