Trial Outcomes & Findings for Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia (NCT NCT00070499)
NCT ID: NCT00070499
Last Updated: 2025-08-21
Results Overview
Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
406 participants
Primary outcome timeframe
pretreatment and after 12 months of treatment
Results posted on
2025-08-21
Participant Flow
Note that 403 patients were registered to the study. Three patients were registered to standard dose imatinib while concurrent randomization was occurring between standard dose imatinib, high dose imatinib, and dasatinib. Those three patients are included in both the standard dose imatinib A and B cohorts.
Participant milestones
| Measure |
Standard Dose Imatinib A
Randomization between occurred between standard dose imatinib A and high dose imatinib. Standard dose imatinib was 400 mg daily.
|
High Dose Imatinib
High dose imatinib was 800 mg daily.
|
Dasatinib
Dasatinib dose was 100 mg daily
|
Standard Dose Imatinib B
Randomization occurred between Standard dose imatinib and dasatinib. Standard dose imatinib was 400 mg daily.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
78
|
126
|
127
|
|
Overall Study
Eligible
|
73
|
73
|
123
|
125
|
|
Overall Study
Eligible and Treated
|
72
|
73
|
123
|
123
|
|
Overall Study
COMPLETED
|
37
|
52
|
6
|
17
|
|
Overall Study
NOT COMPLETED
|
38
|
26
|
120
|
110
|
Reasons for withdrawal
| Measure |
Standard Dose Imatinib A
Randomization between occurred between standard dose imatinib A and high dose imatinib. Standard dose imatinib was 400 mg daily.
|
High Dose Imatinib
High dose imatinib was 800 mg daily.
|
Dasatinib
Dasatinib dose was 100 mg daily
|
Standard Dose Imatinib B
Randomization occurred between Standard dose imatinib and dasatinib. Standard dose imatinib was 400 mg daily.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
6
|
19
|
15
|
|
Overall Study
Refusal unrelated to adverse effects
|
7
|
5
|
5
|
8
|
|
Overall Study
Progression/relapse
|
4
|
2
|
1
|
4
|
|
Overall Study
Death
|
1
|
1
|
1
|
2
|
|
Overall Study
Other - not protocol specified
|
7
|
3
|
12
|
20
|
|
Overall Study
Still on protocol treatment
|
10
|
4
|
79
|
57
|
|
Overall Study
Did not start treatment
|
1
|
0
|
0
|
2
|
|
Overall Study
Not eligible
|
2
|
5
|
3
|
2
|
Baseline Characteristics
Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia
Baseline characteristics by cohort
| Measure |
Standard Dose Imatinib A
n=72 Participants
Randomization between occurred between standard dose imatinib A and high dose imatinib
|
High Dose Imatinib
n=73 Participants
|
Dasatinib
n=123 Participants
|
Standard Dose Imatinib B
n=123 Participants
Randomization occurred between Standard dose imatinib and dasatinib
|
Total
n=391 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
52 years
n=7 Participants
|
47 years
n=5 Participants
|
50 years
n=4 Participants
|
50 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
151 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
240 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
73 participants
n=7 Participants
|
123 participants
n=5 Participants
|
123 participants
n=4 Participants
|
391 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: pretreatment and after 12 months of treatmentPopulation: Patients with follow-up specimens assayed by reverse transcription polymerase chain reaction (RT-PCR)
Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.
Outcome measures
| Measure |
Standard Dose Imatinib A
n=49 Participants
Standard dose imatinib A
|
High Dose Imatinib
n=55 Participants
High dose imatinib
|
Dasatinib
n=99 Participants
Dasatinib
|
Standard Dose Imatinib B
n=90 Participants
Standard dose imatinib B
|
|---|---|---|---|---|
|
Molecular Response Rate at 12 Months
|
5 participants
|
14 participants
|
27 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 1 month after starting treatmentPopulation: Eligible, treated patients who were evaluable for hematologic response
Hematologic response assesses whether patients' blood counts return to normal
Outcome measures
| Measure |
Standard Dose Imatinib A
n=72 Participants
Standard dose imatinib A
|
High Dose Imatinib
n=72 Participants
High dose imatinib
|
Dasatinib
n=123 Participants
Dasatinib
|
Standard Dose Imatinib B
n=123 Participants
Standard dose imatinib B
|
|---|---|---|---|---|
|
Hematologic Response
|
63 participants
|
66 participants
|
107 participants
|
112 participants
|
SECONDARY outcome
Timeframe: Every three months for the first year, every six months in years 2 and 3, and annually for years 4 and 5Population: All eligible patients who were treated
Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.
Outcome measures
| Measure |
Standard Dose Imatinib A
n=72 Participants
Standard dose imatinib A
|
High Dose Imatinib
n=73 Participants
High dose imatinib
|
Dasatinib
n=123 Participants
Dasatinib
|
Standard Dose Imatinib B
n=123 Participants
Standard dose imatinib B
|
|---|---|---|---|---|
|
2-year Overall Survival (OS)
|
89 Percent of population
|
95 Percent of population
|
97 Percent of population
|
98 Percent of population
|
SECONDARY outcome
Timeframe: every 3 months for the first year, every six months for years 2 and 3, annually for years 4 and 5Population: Eligible, treated patients who achieved a hematologic complete remission
Relapse-free survival is measured from the date of documented (possibly unconfirmed) hematologic complete remission until loss of hematologic complete remission or death from any cause. Observations are censored at the date of last contact for patients last known to be alive with report of loss of hematologic complete remission.
Outcome measures
| Measure |
Standard Dose Imatinib A
n=63 Participants
Standard dose imatinib A
|
High Dose Imatinib
n=66 Participants
High dose imatinib
|
Dasatinib
n=107 Participants
Dasatinib
|
Standard Dose Imatinib B
n=112 Participants
Standard dose imatinib B
|
|---|---|---|---|---|
|
Two Year Relapse-free Survival
|
83 Percent of population
|
97 Percent of population
|
96 Percent of population
|
95 Percent of population
|
SECONDARY outcome
Timeframe: Patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.Population: Eligible patients who started therapy
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Outcome measures
| Measure |
Standard Dose Imatinib A
n=72 Participants
Standard dose imatinib A
|
High Dose Imatinib
n=72 Participants
High dose imatinib
|
Dasatinib
n=122 Participants
Dasatinib
|
Standard Dose Imatinib B
n=123 Participants
Standard dose imatinib B
|
|---|---|---|---|---|
|
Toxicity
Vision-blurred vision
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Vomiting
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Watery eye (epiphora, tearing)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Weight gain
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
3 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Infection with Grade 3/4 neut - Lung (pneumon
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
2 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Pain - Back
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Pain - Bone
|
1 Participants with a given type of AE
|
3 Participants with a given type of AE
|
2 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Pain - Chest/thorax NOS
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Syncope (fainting)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Pain - Extremity-limb
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Pain - Head/headache
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
3 Participants with a given type of AE
|
3 Participants with a given type of AE
|
|
Toxicity
Pain - Joint
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
2 Participants with a given type of AE
|
|
Toxicity
Pain - Muscle
|
1 Participants with a given type of AE
|
3 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Vaginal mucositis
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Pain-Other (Specify)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Pericardial effusion (non-malignant)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
3 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Phosphate, serum-low (hypophosphatemia)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Platelets
|
6 Participants with a given type of AE
|
14 Participants with a given type of AE
|
22 Participants with a given type of AE
|
11 Participants with a given type of AE
|
|
Toxicity
Pleural effusion (non-malignant)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
4 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Potassium, serum-high (hyperkalemia)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Potassium, serum-low (hypokalemia)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
2 Participants with a given type of AE
|
|
Toxicity
Prolonged QTc interval
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Proteinuria
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Pruritus/itching
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
2 Participants with a given type of AE
|
|
Toxicity
Pulmonary/Upper Respiratory-Other (Specify)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Rash/desquamation
|
1 Participants with a given type of AE
|
4 Participants with a given type of AE
|
0 Participants with a given type of AE
|
2 Participants with a given type of AE
|
|
Toxicity
Rash: acne/acneiform
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Restrictive cardiomyopathy
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Retinal detachment
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Sodium, serum-high (hypernatremia)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1 Participants with a given type of AE
|
3 Participants with a given type of AE
|
1 Participants with a given type of AE
|
3 Participants with a given type of AE
|
|
Toxicity
AST, SGOT (serum glutamic oxaloacetic trans.)
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
2 Participants with a given type of AE
|
|
Toxicity
Bilirubin (hyperbilirubinemia)
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Bronchospasm, wheezing
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
CNS cerebrovascular ischemia
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
CPK (creatine phosphokinase)
|
3 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Cardiac-ischemia/infarction
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
2 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Colitis
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
3 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Conduction abnor/Atrioventricular heart block
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Constipation
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Dehydration
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Diarrhea
|
1 Participants with a given type of AE
|
6 Participants with a given type of AE
|
6 Participants with a given type of AE
|
2 Participants with a given type of AE
|
|
Toxicity
Distention/bloating, abdominal
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Dizziness
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Dyspnea (shortness of breath)
|
0 Participants with a given type of AE
|
2 Participants with a given type of AE
|
7 Participants with a given type of AE
|
2 Participants with a given type of AE
|
|
Toxicity
Edema: head and neck
|
2 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
2 Participants with a given type of AE
|
|
Toxicity
Edema: limb
|
0 Participants with a given type of AE
|
2 Participants with a given type of AE
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Edema: trunk/genital
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Edema: viscera
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Fatigue (asthenia, lethargy, malaise)
|
0 Participants with a given type of AE
|
11 Participants with a given type of AE
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Febrile neutropenia
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
3 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
GGT (gamma-glutamyl transpeptidase)
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Glucose, serum-high (hyperglycemia)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
3 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Hematoma
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Hemoglobin
|
5 Participants with a given type of AE
|
8 Participants with a given type of AE
|
12 Participants with a given type of AE
|
5 Participants with a given type of AE
|
|
Toxicity
Hepatobiliary/Pancreas-Other (Specify)
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Hot flashes/flushes
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Hypertension
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Hypoxia
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Infection with Grade 3 or 4 neutrophils - Blood
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Infec with norm ANC or Grade 1 or 2 neut - Colon
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Inf with no ANC or Grade 1/2 netLung (pneumonia)
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
2 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Infec with norm ANC or Grade 1 or 2 neut - Scrotum
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Infect with norm ANC or Grade 1 or 2 neut - Sinus
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Inf with no ANC or Grade 1/2 neut - Ur tract NOS
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Infection with unknown ANC - Sinus
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Left ventricular diastolic dysfunction
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Leukocytes (total WBC)
|
1 Participants with a given type of AE
|
2 Participants with a given type of AE
|
3 Participants with a given type of AE
|
3 Participants with a given type of AE
|
|
Toxicity
Lymphopenia
|
1 Participants with a given type of AE
|
1 Participants with a given type of AE
|
3 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Metabolic/Laboratory-Other (Specify)
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Mood alteration - depression
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Mucositis/stomatitis (clinical exam) - Oral cavity
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
2 Participants with a given type of AE
|
|
Toxicity
Muscle weak, not due to neurop. Whole body/general
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Nausea
|
2 Participants with a given type of AE
|
2 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
|
Toxicity
Neuropathy: motor
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Neuropathy: sensory
|
0 Participants with a given type of AE
|
0 Participants with a given type of AE
|
1 Participants with a given type of AE
|
0 Participants with a given type of AE
|
|
Toxicity
Neutrophils/granulocytes (ANC/AGC)
|
8 Participants with a given type of AE
|
12 Participants with a given type of AE
|
18 Participants with a given type of AE
|
15 Participants with a given type of AE
|
|
Toxicity
Pain - Abdomen NOS
|
1 Participants with a given type of AE
|
4 Participants with a given type of AE
|
3 Participants with a given type of AE
|
1 Participants with a given type of AE
|
Adverse Events
Standard Dose Imatinib A
Serious events: 4 serious events
Other events: 71 other events
Deaths: 0 deaths
High Dose Imatinib
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Dasatinib
Serious events: 20 serious events
Other events: 115 other events
Deaths: 0 deaths
Standard Dose Imatinib B
Serious events: 0 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Dose Imatinib A
n=72 participants at risk
Randomization occurred between standard dose imatinib A and high dose imatinib/ patients received 400 mg imatinib daily
|
High Dose Imatinib
n=72 participants at risk
Patients received 800 mg imatinib daily
|
Dasatinib
n=122 participants at risk
Patients received 100 mg dasatinib daily
|
Standard Dose Imatinib B
n=123 participants at risk
Randomization occurred between Standard dose imatinib B and dasatinib/ patients received 400 mg imatinib daily
|
|---|---|---|---|---|
|
General disorders
Edema: limb
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.8%
2/72 • Number of events 2 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
1.6%
2/122 • Number of events 2 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
1.6%
2/122 • Number of events 2 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Ulcer, GI - Duodenum
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Scrotum
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
CPK (creatine phosphokinase)
|
1.4%
1/72 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
1.4%
1/72 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Platelets
|
1.4%
1/72 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Prolonged QTc interval
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Weight gain
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Nervous system disorders
Pain - Head/headache
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Psychiatric disorders
Mood alteration - depression
|
1.4%
1/72 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
1.6%
2/122 • Number of events 2 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
2.5%
3/122 • Number of events 3 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
4.1%
5/122 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Vascular disorders
Hematoma
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.82%
1/122 • Number of events 1 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
Other adverse events
| Measure |
Standard Dose Imatinib A
n=72 participants at risk
Randomization occurred between standard dose imatinib A and high dose imatinib/ patients received 400 mg imatinib daily
|
High Dose Imatinib
n=72 participants at risk
Patients received 800 mg imatinib daily
|
Dasatinib
n=122 participants at risk
Patients received 100 mg dasatinib daily
|
Standard Dose Imatinib B
n=123 participants at risk
Randomization occurred between Standard dose imatinib B and dasatinib/ patients received 400 mg imatinib daily
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
65.3%
47/72 • Number of events 47 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
81.9%
59/72 • Number of events 59 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
70.5%
86/122 • Number of events 86 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
70.7%
87/123 • Number of events 87 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Eye disorders
Vision-blurred vision
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.6%
4/72 • Number of events 4 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.7%
7/123 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
13.9%
10/72 • Number of events 10 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
10.6%
13/123 • Number of events 13 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.3%
6/72 • Number of events 6 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Constipation
|
5.6%
4/72 • Number of events 4 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.3%
6/72 • Number of events 6 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
7.4%
9/122 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
7.3%
9/123 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Diarrhea
|
36.1%
26/72 • Number of events 26 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
55.6%
40/72 • Number of events 40 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
33.6%
41/122 • Number of events 41 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
41.5%
51/123 • Number of events 51 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.7%
7/123 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
12.5%
9/72 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.0%
11/122 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
7.3%
9/123 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
9.7%
7/72 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
26.4%
19/72 • Number of events 19 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.8%
12/122 • Number of events 12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
17.9%
22/123 • Number of events 22 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
50.0%
36/72 • Number of events 36 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
58.3%
42/72 • Number of events 42 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
27.0%
33/122 • Number of events 33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
51.2%
63/123 • Number of events 63 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
9.7%
7/72 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
26.4%
19/72 • Number of events 19 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
13.1%
16/122 • Number of events 16 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
13.0%
16/123 • Number of events 16 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
15.3%
11/72 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
26.4%
19/72 • Number of events 19 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
15.6%
19/122 • Number of events 19 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
20.3%
25/123 • Number of events 25 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Edema: head and neck
|
38.9%
28/72 • Number of events 28 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
59.7%
43/72 • Number of events 43 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
11.5%
14/122 • Number of events 14 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
36.6%
45/123 • Number of events 45 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Edema: limb
|
36.1%
26/72 • Number of events 26 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
40.3%
29/72 • Number of events 29 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
17.2%
21/122 • Number of events 21 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
29.3%
36/123 • Number of events 36 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Edema: trunk/genital
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.6%
4/72 • Number of events 4 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
65.3%
47/72 • Number of events 47 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
79.2%
57/72 • Number of events 57 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
54.1%
66/122 • Number of events 66 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
54.5%
67/123 • Number of events 67 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
|
5.6%
4/72 • Number of events 4 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
12.5%
9/72 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
12.3%
15/122 • Number of events 15 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.7%
7/123 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.7%
7/72 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.0%
11/122 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Rigors/chills
|
5.6%
4/72 • Number of events 4 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
8.3%
6/72 • Number of events 6 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
16.7%
12/72 • Number of events 12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
16.4%
20/122 • Number of events 20 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
12.2%
15/123 • Number of events 15 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
12.5%
9/72 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
25.0%
18/72 • Number of events 18 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
18.9%
23/122 • Number of events 23 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
14.6%
18/123 • Number of events 18 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Alkaline phosphatase
|
19.4%
14/72 • Number of events 14 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
31.9%
23/72 • Number of events 23 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
16.4%
20/122 • Number of events 20 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
21.1%
26/123 • Number of events 26 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
15.3%
11/72 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.7%
7/122 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Creatinine
|
13.9%
10/72 • Number of events 10 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
16.7%
12/72 • Number of events 12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
10.7%
13/122 • Number of events 13 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
14.6%
18/123 • Number of events 18 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Leukocytes (total WBC)
|
19.4%
14/72 • Number of events 14 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
38.9%
28/72 • Number of events 28 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
27.9%
34/122 • Number of events 34 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
28.5%
35/123 • Number of events 35 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Lymphopenia
|
11.1%
8/72 • Number of events 8 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
11.1%
8/72 • Number of events 8 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.2%
10/122 • Number of events 10 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
6.5%
8/123 • Number of events 8 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Metabolic/Laboratory-Other (Specify)
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
30.6%
22/72 • Number of events 22 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
45.8%
33/72 • Number of events 33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
37.7%
46/122 • Number of events 46 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
36.6%
45/123 • Number of events 45 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Platelets
|
31.9%
23/72 • Number of events 23 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
63.9%
46/72 • Number of events 46 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
58.2%
71/122 • Number of events 71 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
34.1%
42/123 • Number of events 42 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Prolonged QTc interval
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.7%
7/72 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Weight gain
|
8.3%
6/72 • Number of events 6 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
23.6%
17/72 • Number of events 17 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
14.8%
18/122 • Number of events 18 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
13.8%
17/123 • Number of events 17 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
16.7%
12/72 • Number of events 12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
7.4%
9/122 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
15.3%
11/72 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
22.2%
16/72 • Number of events 16 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
18.0%
22/122 • Number of events 22 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.8%
12/123 • Number of events 12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
5.6%
4/72 • Number of events 4 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
13.9%
10/72 • Number of events 10 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.8%
12/122 • Number of events 12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.1%
10/123 • Number of events 10 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
13.9%
10/72 • Number of events 10 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
15.3%
11/72 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
12.3%
15/122 • Number of events 15 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.6%
4/72 • Number of events 4 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
7.4%
9/122 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
7.3%
9/123 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.3%
6/72 • Number of events 6 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.7%
7/123 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
12.5%
9/72 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
15.3%
11/72 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
7.4%
9/122 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
6.5%
8/123 • Number of events 8 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
15.3%
11/72 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
20.8%
15/72 • Number of events 15 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
21.3%
26/122 • Number of events 26 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
17.1%
21/123 • Number of events 21 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
30.6%
22/72 • Number of events 22 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
40.3%
29/72 • Number of events 29 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
12.3%
15/122 • Number of events 15 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
38.2%
47/123 • Number of events 47 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Nervous system disorders
Dizziness
|
5.6%
4/72 • Number of events 4 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
12.5%
9/72 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
10.7%
13/122 • Number of events 13 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.1%
10/123 • Number of events 10 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.6%
4/72 • Number of events 4 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
12.3%
15/122 • Number of events 15 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Nervous system disorders
Pain - Head/headache
|
12.5%
9/72 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
12.5%
9/72 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
27.0%
33/122 • Number of events 33 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
18.7%
23/123 • Number of events 23 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
12.5%
9/72 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
6.5%
8/123 • Number of events 8 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Psychiatric disorders
Insomnia
|
11.1%
8/72 • Number of events 8 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
13.9%
10/72 • Number of events 10 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.9%
11/123 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Psychiatric disorders
Mood alteration - depression
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.3%
6/72 • Number of events 6 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
6.6%
8/122 • Number of events 8 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.7%
7/72 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
7.4%
9/122 • Number of events 9 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.7%
7/123 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.3%
6/72 • Number of events 6 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
18.0%
22/122 • Number of events 22 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.8%
12/123 • Number of events 12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.7%
7/122 • Number of events 7 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
13.1%
16/122 • Number of events 16 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/122 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
5.6%
4/72 • Number of events 4 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.3%
6/72 • Number of events 6 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.0%
11/122 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.1%
10/123 • Number of events 10 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.3%
6/72 • Number of events 6 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
27.8%
20/72 • Number of events 20 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.0%
11/122 • Number of events 11 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
14.6%
18/123 • Number of events 18 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
26.4%
19/72 • Number of events 19 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
50.0%
36/72 • Number of events 36 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
33.6%
41/122 • Number of events 41 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
28.5%
35/123 • Number of events 35 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/72 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.8%
12/122 • Number of events 12 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/123 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
6.9%
5/72 • Number of events 5 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
13.9%
10/72 • Number of events 10 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
6.6%
8/122 • Number of events 8 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
11.4%
14/123 • Number of events 14 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
Additional Information
SWOG Leukemia Statistician
SWOG Statistical Office
Phone: 206-667-4408
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60