Trial Outcomes & Findings for Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib (NCT NCT00320190)
NCT ID: NCT00320190
Last Updated: 2013-10-30
Results Overview
MMolR is defined as reduction in transcript levels of the breakpoint cluster region (BCR)-V-abl Abelson murine leukemia viral oncogene homolog 1 (ABL) gene of at least 3 log. The BCR-ABL gene has a role in the production of a mutated protein that converts bone marrow stem cells from normal to leukemic.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
At 12 months from baseline
Results posted on
2013-10-30
Participant Flow
Of 52 participants enrolled, 32 were randomized to treatment. Of the 20 not randomized, 17 no longer met study criteria, 1 participant had an adverse event prior to randomization, 1 participant was enrolled after the sponsor stopped recruitment, and 1 participant was stopped due to administrative reasons.
Participant milestones
| Measure |
Dasatinib, 100 mg
Dasatinib, 100 mg, administered orally once daily.
|
Imatinib, 800 mg
Imatinib, 400 mg, administered orally twice daily.
|
|---|---|---|
|
First 12 Months
STARTED
|
19
|
13
|
|
First 12 Months
COMPLETED
|
11
|
3
|
|
First 12 Months
NOT COMPLETED
|
8
|
10
|
|
Long-term (12-month) Extension
STARTED
|
11
|
3
|
|
Long-term (12-month) Extension
COMPLETED
|
2
|
1
|
|
Long-term (12-month) Extension
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
Dasatinib, 100 mg
Dasatinib, 100 mg, administered orally once daily.
|
Imatinib, 800 mg
Imatinib, 400 mg, administered orally twice daily.
|
|---|---|---|
|
First 12 Months
Completed but did not enter extension
|
5
|
3
|
|
First 12 Months
Sponsor terminated study
|
2
|
2
|
|
First 12 Months
Lost to Follow-up
|
0
|
1
|
|
First 12 Months
Enrollment failure
|
0
|
1
|
|
First 12 Months
Adverse event unrelated to study drug
|
1
|
0
|
|
First 12 Months
Investigator request
|
0
|
1
|
|
First 12 Months
Study drug toxicity
|
0
|
1
|
|
First 12 Months
Withdrawal by Subject
|
0
|
1
|
|
Long-term (12-month) Extension
Sponsor terminated study
|
7
|
0
|
|
Long-term (12-month) Extension
Lack of major molecular response
|
1
|
2
|
|
Long-term (12-month) Extension
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib
Baseline characteristics by cohort
| Measure |
Dasatinib, 100 mg
n=19 Participants
Dasatinib, 100 mg, administered orally once daily.
|
Imatinib, 800 mg
n=13 Participants
Imatinib, 400 mg, administered orally twice daily.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
45.5 Years
STANDARD_DEVIATION 14.83 • n=5 Participants
|
53.2 Years
STANDARD_DEVIATION 14.24 • n=7 Participants
|
48.6 Years
STANDARD_DEVIATION 14.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12 months from baselinePopulation: Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.
MMolR is defined as reduction in transcript levels of the breakpoint cluster region (BCR)-V-abl Abelson murine leukemia viral oncogene homolog 1 (ABL) gene of at least 3 log. The BCR-ABL gene has a role in the production of a mutated protein that converts bone marrow stem cells from normal to leukemic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Months 1 to 12, continuously, and Months 12 to 24, continuouslyPopulation: All participants who received at least 1 dose of dasatinib or imatinib.
AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, persistent or significant disability/incapacity, drug dependency, or drug abuse; prolongs inpatient hospitalization; or is life-threatening, a congenital anomaly/birth defect, or an important medical event. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Outcome measures
| Measure |
Dasatinib, 100 mg
n=19 Participants
Dasatinib, 100 mg, administered orally once daily.
|
Imatinib, 800 mg
n=13 Participants
Imatinib, 400 mg, administered orally twice daily.
|
|---|---|---|
|
Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation
AEs leading to discontinuation
|
5.3 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation
AEs
|
94.7 Percentage of participants
|
92.3 Percentage of participants
|
|
Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation
Treatment-related AEs
|
78.9 Percentage of participants
|
92.3 Percentage of participants
|
|
Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation
SAEs
|
15.8 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation
Treatment-related SAEs
|
5.3 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation
Deaths
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Months 1 to 12, continuously, and Months 12 to 24, continuouslyPopulation: All participants who received at least 1 dose of dasatinib or imatinib.
GI=gastrointestinal. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Grade 1=mild; Grade 2=moderate; Grade 3=severe and undesirable; Grade 4=life-threatening or disabling; Grade 5=death. Percentages based on the number of participants with a specific grade at baseline. Participants without on-study test values for a particular laboratory analyte are not included in the reporting of that analyte.
Outcome measures
| Measure |
Dasatinib, 100 mg
n=19 Participants
Dasatinib, 100 mg, administered orally once daily.
|
Imatinib, 800 mg
n=13 Participants
Imatinib, 400 mg, administered orally twice daily.
|
|---|---|---|
|
Percentage of Participants With On-study AEs of Special Interest
Fluid retention (Any grade)
|
5.3 Percentage of Participants
|
38.5 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Fluid retention: Superficial edema (Grades 3-5)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Fluid retention: Generalized edema (Any grade)
|
5.3 Percentage of Participants
|
7.7 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Fluid retention: Generalized edema (Grades 3-5)
|
0 Percentage of Participants
|
7.7 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Hemorrhage (Any grade)
|
0 Percentage of Participants
|
15.4 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Hemorrhage: GI bleeding (Any grade)
|
0 Percentage of Participants
|
7.7 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Hemorrhage: GI bleeding (Grades 3-5)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Hemorrhage: Other bleeding (Any grade)
|
0 Percentage of Participants
|
7.7 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Hemorrhage: Other bleeding (Grades 3-5)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Diarrhea (Any grade)
|
26.3 Percentage of Participants
|
30.8 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Diarrhea (Grades 3-5)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Skin rash (Any grade)
|
42.1 Percentage of Participants
|
15.4 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Skin rash (Grades 3-5)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Fluid retention (Grades 3-5)
|
0 Percentage of Participants
|
7.7 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Fluid retention: Superficial edema (Any grade)
|
0 Percentage of Participants
|
30.8 Percentage of Participants
|
|
Percentage of Participants With On-study AEs of Special Interest
Hemorrhage (Grades 3-5)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: At 3, 6, 9, and 12 months from baselinePopulation: Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.
Time to MMolR is defined as the time from first treatment dose until measurement criteria are first met for MMolR. MMolR is defined as a reduction in transcript levels of the BCR-ABL gene of at least 3 log from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 and 12 months from baselinePopulation: Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.
Cytogenetic response is based on the prevalence of Ph+ metaphases among cells in metaphase in a bone marrow sample.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to disease progression, death, or discontinuation (to 12 months)Population: Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.
Time to treatment failure is defined as the time in days from randomization to progressive disease documented by the investigator, to death from any cause without prior progression, or to early treatment discontinuation for any reason, whichever occurs first. Participants without disease progression or who do not die and complete the 12-month study treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to disease progression or death (to 12 months)Population: Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.
Progression-free survival is defined as the time in days from randomization to progressive disease documented by the investigator or to death from any cause without prior progression. Participants without progressive disease or who do not die and complete the 12-month treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.
Outcome measures
Outcome data not reported
Adverse Events
Dasatinib, 100 mg
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Imatinib, 800 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib, 100 mg
n=19 participants at risk
Dasatinib, 100 mg, administered orally once daily.
|
Imatinib, 800 mg
n=13 participants at risk
Imatinib, 400 mg, administered orally twice daily
|
|---|---|---|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
PNEUMONIA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
SKIN BURNING SENSATION
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
Other adverse events
| Measure |
Dasatinib, 100 mg
n=19 participants at risk
Dasatinib, 100 mg, administered orally once daily.
|
Imatinib, 800 mg
n=13 participants at risk
Imatinib, 400 mg, administered orally twice daily
|
|---|---|---|
|
Eye disorders
EYE PAIN
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Eye disorders
EYE SWELLING
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Eye disorders
EYE DISCHARGE
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Eye disorders
EYELID OEDEMA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
15.4%
2/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Eye disorders
ORBITAL OEDEMA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Eye disorders
OCULAR HYPERAEMIA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
15.4%
2/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Eye disorders
DACRYOSTENOSIS ACQUIRED
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
BIOPSY
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
CARDIAC MURMUR
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
WEIGHT DECREASED
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
BLOOD CALCIUM INCREASED
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
ELECTROCARDIOGRAM QT INTERVAL
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Vascular disorders
FLUSHING
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Vascular disorders
HYPERTENSION
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Endocrine disorders
GOITRE
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Psychiatric disorders
INSOMNIA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Psychiatric disorders
AGGRESSION
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Immune system disorders
SEASONAL ALLERGY
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Nervous system disorders
HEADACHE
|
42.1%
8/19 • Baseline to Month 12 and Month 12 to Month 24
|
30.8%
4/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Nervous system disorders
DIZZINESS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Nervous system disorders
FACIAL PALSY
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Nervous system disorders
FACIAL NEURALGIA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
NAUSEA
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
53.8%
7/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
VOMITING
|
15.8%
3/19 • Baseline to Month 12 and Month 12 to Month 24
|
38.5%
5/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
DIARRHOEA
|
26.3%
5/19 • Baseline to Month 12 and Month 12 to Month 24
|
30.8%
4/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
FLATULENCE
|
15.8%
3/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
LIP BLISTER
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
CONSTIPATION
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
DENTAL CARIES
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
TOOTH DISORDER
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
15.8%
3/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL SPHINCTER INSUFFICIENCY
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Ear and labyrinth disorders
TINNITUS
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
INFECTION
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
INFLUENZA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
SINUSITIS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
BRONCHITIS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
TONSILLITIS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
LABYRINTHITIS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
ONYCHOMYCOSIS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
GASTROENTERITIS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
15.4%
2/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
TOOTH INFECTION
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
LOCALISED INFECTION
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Renal and urinary disorders
NOCTURIA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Renal and urinary disorders
PROTEINURIA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Metabolism and nutrition disorders
GOUT
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Blood and lymphatic system disorders
LYMPHOCYTOSIS
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
RASH
|
31.6%
6/19 • Baseline to Month 12 and Month 12 to Month 24
|
15.4%
2/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
PERIORBITAL OEDEMA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
15.4%
2/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Skin and subcutaneous tissue disorders
SKIN BURNING SENSATION
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Reproductive system and breast disorders
BREAST MASS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Reproductive system and breast disorders
EPIDIDYMAL CYST
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Reproductive system and breast disorders
PRURITUS GENITAL
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
15.8%
3/19 • Baseline to Month 12 and Month 12 to Month 24
|
15.4%
2/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
21.1%
4/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
23.1%
3/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.8%
3/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Respiratory, thoracic and mediastinal disorders
ORTHOPNOEA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
15.4%
2/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM DISCOLOURED
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
15.4%
2/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Respiratory, thoracic and mediastinal disorders
INCREASED BRONCHIAL SECRETION
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
General disorders
CHILLS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
General disorders
OEDEMA
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
General disorders
FATIGUE
|
36.8%
7/19 • Baseline to Month 12 and Month 12 to Month 24
|
23.1%
3/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
General disorders
MALAISE
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
General disorders
PYREXIA
|
26.3%
5/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
General disorders
ASTHENIA
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
23.1%
3/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
General disorders
CHEST PAIN
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
General disorders
FACIAL PAIN
|
0.00%
0/19 • Baseline to Month 12 and Month 12 to Month 24
|
7.7%
1/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
General disorders
AXILLARY PAIN
|
10.5%
2/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
15.8%
3/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
5.3%
1/19 • Baseline to Month 12 and Month 12 to Month 24
|
0.00%
0/13 • Baseline to Month 12 and Month 12 to Month 24
|
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