Trial Outcomes & Findings for Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (NCT NCT00982488)
NCT ID: NCT00982488
Last Updated: 2016-01-22
Results Overview
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
238 participants
Primary outcome timeframe
Day 1 of treatment through a maximum of 82 months + 30 days
Results posted on
2016-01-22
Participant Flow
A total of 238 patients were enrolled: 200 with chronic phase chronic myelogenous leukemia (CML) and 38 with advanced phase disease (34 with acclelerated phase CML, 3 with myeloid blast phase CML, and 1 with Philadelphia chromosome positive acute lymphoblastic leukemia.) All but 1 CML patient, who no longer met study criteria, received treatment.
Participant milestones
| Measure |
Dasatinib 50 mg QD to 120 mg BID, Chronic Phase
Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Imatinib, 400 mg BID, Chronic Phase
Participants chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
Participants with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB
Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
185
|
14
|
34
|
3
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
185
|
14
|
34
|
3
|
1
|
Reasons for withdrawal
| Measure |
Dasatinib 50 mg QD to 120 mg BID, Chronic Phase
Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Imatinib, 400 mg BID, Chronic Phase
Participants chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
Participants with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB
Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
|---|---|---|---|---|---|
|
Overall Study
Administrative reason by sponsor
|
81
|
3
|
11
|
0
|
0
|
|
Overall Study
Adverse event unrelated to study drug
|
5
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
11
|
0
|
2
|
0
|
0
|
|
Overall Study
Disease progression
|
30
|
5
|
10
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Maximum clinical benefit
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Other
|
15
|
1
|
3
|
1
|
0
|
|
Overall Study
Poor compliance/noncompliance
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Stem cell transplant
|
2
|
0
|
0
|
1
|
0
|
|
Overall Study
Study drug toxicity
|
34
|
1
|
6
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Dasatinib 50 mg QD to 120 mg BID, Chronic Phase
n=185 Participants
Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Imatinib, 400 mg BID, Chronic Phase
n=14 Participants
Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
n=34 Participants
Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB
n=3 Participants
Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
n=1 Participants
Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Younger than 21 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
21-45 years
|
46 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
|
Age, Customized
46-65 years
|
88 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
114 Participants
n=8 Participants
|
|
Age, Customized
66-75 years
|
40 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Age, Customized
Older than 75 years
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
115 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
122 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
167 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
206 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 of treatment through a maximum of 82 months + 30 daysPopulation: All participants who received at least 1 dose of study drug
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.
Outcome measures
| Measure |
Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase
n=185 Participants
Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Imatinib, 400 mg BID, Chronic Phase
n=14 Participants
Participants with chronic phase disease received 400 mg of imatinib twice daily (BID). Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
n=34 Participants
Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP
n=3 Participants
Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
n=1 Participants
Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
|---|---|---|---|---|---|
|
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
All deaths
|
22 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
Deaths within 30 days of last dose
|
9 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
SAEs
|
57 Participants
|
3 Participants
|
15 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
Drug-related SAEs
|
28 Participants
|
2 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
AEs leading to discontinuation
|
39 Participants
|
1 Participants
|
10 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
Drug-related AEs leading to discontinuation
|
29 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
Drug-related AEs
|
140 Participants
|
7 Participants
|
27 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
Drug-related AEs of special interest
|
111 Participants
|
4 Participants
|
20 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase
Serious events: 57 serious events
Other events: 138 other events
Deaths: 0 deaths
Imatinib, 400 mg BID, Chronic Phase
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
Serious events: 15 serious events
Other events: 24 other events
Deaths: 0 deaths
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase
n=185 participants at risk
Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Imatinib, 400 mg BID, Chronic Phase
n=14 participants at risk
Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
n=34 participants at risk
Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP
n=3 participants at risk
Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL
n=1 participants at risk
Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.00%
0/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
100.0%
1/1
|
|
Infections and infestations
Appendicitis
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
2/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Psychiatric disorders
Depression
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Disease progression
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
2/185
|
7.1%
1/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Oedema peripheral
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Surgical and medical procedures
Oophorectomy bilateral
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Cardiac disorders
Bradyarrhythmia
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Chest pain
|
0.54%
1/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Effusion
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/185
|
0.00%
0/14
|
0.00%
0/34
|
33.3%
1/3
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Renal and urinary disorders
Renal failure acute
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Death
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Pain
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.0%
13/185
|
7.1%
1/14
|
8.8%
3/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Ascites
|
1.1%
2/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Cellulitis
|
1.1%
2/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Volvulus
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
3/185
|
0.00%
0/14
|
8.8%
3/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.54%
1/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.1%
2/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Pyrexia
|
2.7%
5/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Eye disorders
Retinal artery occlusion
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac failure
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Vascular disorders
Deep vein thrombosis
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Vascular disorders
Hypotension
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Infection
|
1.6%
3/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Cardiac disorders
Myocardial infarction
|
0.54%
1/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Vascular disorders
Thrombosis
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
2/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Social circumstances
Elderly
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Erysipelas
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Localised infection
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Pneumonia
|
2.7%
5/185
|
0.00%
0/14
|
8.8%
3/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Sepsis
|
1.6%
3/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Staphylococcal infection
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Sudden death
|
1.1%
2/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Eye disorders
Vision blurred
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.54%
1/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.54%
1/185
|
0.00%
0/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Obesity
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
2/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Vascular disorders
Peripheral ischaemia
|
0.54%
1/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
100.0%
1/1
|
Other adverse events
| Measure |
Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase
n=185 participants at risk
Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Imatinib, 400 mg BID, Chronic Phase
n=14 participants at risk
Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
n=34 participants at risk
Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP
n=3 participants at risk
Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL
n=1 participants at risk
Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/185
|
0.00%
0/14
|
0.00%
0/34
|
33.3%
1/3
|
0.00%
0/1
|
|
Nervous system disorders
Dizziness
|
7.0%
13/185
|
0.00%
0/14
|
5.9%
2/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.1%
2/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Psychiatric disorders
Insomnia
|
3.2%
6/185
|
7.1%
1/14
|
2.9%
1/34
|
33.3%
1/3
|
0.00%
0/1
|
|
Nervous system disorders
Neuropathy peripheral
|
1.1%
2/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Oedema peripheral
|
13.5%
25/185
|
7.1%
1/14
|
11.8%
4/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
12/185
|
0.00%
0/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.8%
31/185
|
0.00%
0/14
|
11.8%
4/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Viral infection
|
1.1%
2/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Investigations
Aspartate aminotransferase increased
|
0.54%
1/185
|
0.00%
0/14
|
2.9%
1/34
|
33.3%
1/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
2/185
|
7.1%
1/14
|
5.9%
2/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Gastroenteritis
|
1.1%
2/185
|
7.1%
1/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
3/185
|
0.00%
0/14
|
0.00%
0/34
|
33.3%
1/3
|
0.00%
0/1
|
|
Renal and urinary disorders
Proteinuria
|
1.1%
2/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Renal and urinary disorders
Renal failure
|
0.54%
1/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
8/185
|
7.1%
1/14
|
8.8%
3/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Constipation
|
4.9%
9/185
|
7.1%
1/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Vascular disorders
Hypertension
|
6.5%
12/185
|
0.00%
0/14
|
8.8%
3/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
8/185
|
7.1%
1/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
36.2%
67/185
|
7.1%
1/14
|
50.0%
17/34
|
33.3%
1/3
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
5/185
|
0.00%
0/14
|
5.9%
2/34
|
33.3%
1/3
|
0.00%
0/1
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
10/185
|
7.1%
1/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
3/185
|
7.1%
1/14
|
5.9%
2/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
19/185
|
14.3%
2/14
|
5.9%
2/34
|
33.3%
1/3
|
0.00%
0/1
|
|
General disorders
Face oedema
|
1.1%
2/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Fatigue
|
13.5%
25/185
|
7.1%
1/14
|
8.8%
3/34
|
33.3%
1/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.1%
2/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
2/185
|
0.00%
0/14
|
5.9%
2/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
14/185
|
0.00%
0/14
|
2.9%
1/34
|
33.3%
1/3
|
0.00%
0/1
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.8%
33/185
|
0.00%
0/14
|
14.7%
5/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
8/185
|
7.1%
1/14
|
8.8%
3/34
|
0.00%
0/3
|
0.00%
0/1
|
|
General disorders
Pyrexia
|
8.1%
15/185
|
7.1%
1/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Investigations
Blood bilirubin
|
0.00%
0/185
|
0.00%
0/14
|
5.9%
2/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
20/185
|
0.00%
0/14
|
11.8%
4/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/185
|
0.00%
0/14
|
5.9%
2/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Investigations
Lipase increased
|
0.00%
0/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
4.3%
8/185
|
0.00%
0/14
|
5.9%
2/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Fungal skin infection
|
0.54%
1/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Gastrointestinal infection
|
0.54%
1/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Nervous system disorders
Headache
|
7.6%
14/185
|
7.1%
1/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Localised infection
|
0.00%
0/185
|
0.00%
0/14
|
5.9%
2/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
11/185
|
7.1%
1/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.3%
8/185
|
0.00%
0/14
|
8.8%
3/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
7/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/185
|
0.00%
0/14
|
0.00%
0/34
|
33.3%
1/3
|
0.00%
0/1
|
|
Infections and infestations
Sinusitis
|
1.1%
2/185
|
7.1%
1/14
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
4/185
|
21.4%
3/14
|
2.9%
1/34
|
0.00%
0/3
|
0.00%
0/1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER