Trial Outcomes & Findings for Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib (NCT NCT02297139)
NCT ID: NCT02297139
Last Updated: 2023-05-06
Results Overview
Number of participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
Prostate Cancer
Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
16
|
Reasons for withdrawal
| Measure |
Prostate Cancer
Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
|---|---|---|
|
Overall Study
Disease progression
|
0
|
1
|
|
Overall Study
Study drug toxicity
|
0
|
4
|
|
Overall Study
Participant request to discontinue study treatment
|
0
|
1
|
|
Overall Study
Maximum clinical benefit
|
1
|
0
|
|
Overall Study
Administrative reason by sponsor
|
0
|
2
|
|
Overall Study
Other reasons
|
0
|
8
|
Baseline Characteristics
Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib
Baseline characteristics by cohort
| Measure |
Prostate Cancer
n=1 Participants
Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
n=16 Participants
Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 Years
n=5 Participants
|
64.5 Years
n=7 Participants
|
62 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)Population: All treated participants
Number of participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
Outcome measures
| Measure |
Prostate Cancer
n=1 Participants
Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
n=16 Participants
Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
|---|---|---|
|
Number of Participants Who Received Dasatinib Treatment
|
1 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)Population: All treated participants
Duration of treatment for participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
Outcome measures
| Measure |
Prostate Cancer
n=1 Participants
Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
n=16 Participants
Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
|---|---|---|
|
Duration of Treatment
|
25.3 Months
Interval 25.3 to 25.3
|
55.9 Months
Interval 4.0 to 75.5
|
SECONDARY outcome
Timeframe: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)Population: All treated participants
Number of Participants with Adverse Events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Outcome measures
| Measure |
Prostate Cancer
n=1 Participants
Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
n=16 Participants
Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
1 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)Population: All treated participants
Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Outcome measures
| Measure |
Prostate Cancer
n=1 Participants
Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
n=16 Participants
Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
|
8 Participants
|
Adverse Events
Prostate Cancer
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
Serious events: 8 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Prostate Cancer
n=1 participants at risk
Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
n=16 participants at risk
Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
Other adverse events
| Measure |
Prostate Cancer
n=1 participants at risk
Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
Chronic Phase - Chronic Myeloid Leukemia (CP-CML)
n=16 participants at risk
Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
18.8%
3/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
General disorders
Asthenia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
General disorders
Fatigue
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
18.8%
3/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
25.0%
4/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Investigations
Blood pressure increased
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Investigations
Blood testosterone increased
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
0.00%
0/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
25.0%
4/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
37.5%
6/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
12.5%
2/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
37.5%
6/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
6.2%
1/16 • Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
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