Trial Outcomes & Findings for A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C (NCT NCT03420768)
NCT ID: NCT03420768
Last Updated: 2022-02-04
Results Overview
The number of participants who achieve ≥ 1 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo. The METAVIR system is used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy of patients with hepatitis C virus (HCV). It assesses liver biopsies for activity grade (A0-A3) and fibrosis stage (Stage 1 - 4). Participants without a measurement at Week 12 are considered non-responders. Activity Grade: A0 = no activity; A1 = mild activity; A2 = moderate activity; A3 = severe activity Fibrosis stage: 1 = portal fibrosis without septa ; 2 = portal fibrosis with few septa; 3 = numerous septa without cirrhosis; 4 = cirrhosis
COMPLETED
PHASE2
61 participants
Week 12
2022-02-04
Participant Flow
Per sponsor decision, Part 2 of the study was not initiated. 61 subjects were randomized and treated in Part 1
Participant milestones
| Measure |
BMS-986263 45 mg QW (Once Weekly)
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
28
|
15
|
|
Overall Study
COMPLETED
|
18
|
28
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
Baseline characteristics by cohort
| Measure |
BMS-986263 45 mg QW (Once Weekly)
n=18 Participants
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
n=28 Participants
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
n=15 Participants
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.2 Years
STANDARD_DEVIATION 7.45 • n=5 Participants
|
59.8 Years
STANDARD_DEVIATION 8.24 • n=7 Participants
|
61.8 Years
STANDARD_DEVIATION 6.47 • n=5 Participants
|
60.4 Years
STANDARD_DEVIATION 7.53 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment
The number of participants who achieve ≥ 1 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo. The METAVIR system is used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy of patients with hepatitis C virus (HCV). It assesses liver biopsies for activity grade (A0-A3) and fibrosis stage (Stage 1 - 4). Participants without a measurement at Week 12 are considered non-responders. Activity Grade: A0 = no activity; A1 = mild activity; A2 = moderate activity; A3 = severe activity Fibrosis stage: 1 = portal fibrosis without septa ; 2 = portal fibrosis with few septa; 3 = numerous septa without cirrhosis; 4 = cirrhosis
Outcome measures
| Measure |
BMS-986263 45 mg QW (Once Weekly)
n=18 Participants
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
n=28 Participants
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
n=15 Participants
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
|---|---|---|---|
|
The Number of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (METAVIR Score) as Determined by Liver Biopsy After 12 Weeks of Treatment
|
3 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment
The change from baseline measurement in Collagen Proportionate Area (CPA) is used to asses the effects of treatment compared to placebo. Assessment of CPA is a method by which the amount (percentage) of collagen in stained tissue sections is analyzed using morphometric image analysis
Outcome measures
| Measure |
BMS-986263 45 mg QW (Once Weekly)
n=18 Participants
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
n=28 Participants
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
n=15 Participants
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
|---|---|---|---|
|
Change From Baseline in Collagen Proportionate Area (CPA) After 12 Weeks of Treatment
|
-0.68 Percent
Standard Deviation 2.479
|
1.36 Percent
Standard Deviation 2.946
|
-0.21 Percent
Standard Deviation 1.646
|
SECONDARY outcome
Timeframe: Week 12Population: Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment
The number of participants with ≥ 1 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo. The Ishak scoring system is used to grade fibrosis in the histology samples. The Ishak system (0 through 6 scale) was developed to grade portal-based liver fibrosis associated with viral hepatitis: 0: No fibrosis 1. Fibrous expansion of some portal areas, with or without short fibrous septa 2. Fibrous expansion of most portal areas, with or without short fibrous septa 3. Fibrous expansion of most portal areas with occasional portal to portal bridging 4. Fibrous expansion of portal areas with marked bridging (portal to portal as well as portal to central) 5. Marked bridging (portal-portal and/or portal-central) with occasional nodules (incomplete cirrhosis) 6. Cirrhosis, probable or definite
Outcome measures
| Measure |
BMS-986263 45 mg QW (Once Weekly)
n=18 Participants
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
n=28 Participants
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
n=15 Participants
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
|---|---|---|---|
|
The Number of Participants With ≥ 1 Stage Improvement in Liver Fibrosis (Ishak Score) After 12 Weeks of Treatment
|
4 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment
The number of participants with ≥ 2 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo. The METAVIR system is used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy of patients with hepatitis C virus (HCV). It assesses liver biopsies for activity grade (A0-A3) and fibrosis stage (Stage 1 - 4). Participants without a measurement at Week 12 are considered non-responders. Activity Grade: A0 = no activity; A1 = mild activity; A2 = moderate activity; A3 = severe activity Fibrosis stage: 1 = portal fibrosis without septa ; 2 = portal fibrosis with few septa; 3 = numerous septa without cirrhosis; 4 = cirrhosis
Outcome measures
| Measure |
BMS-986263 45 mg QW (Once Weekly)
n=18 Participants
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
n=28 Participants
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
n=15 Participants
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
|---|---|---|---|
|
The Number of Participants With ≥ 2 Stage Improvement in Liver Fibrosis (METAVIR Score) After 12 Weeks of Treatment
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment
The number of participants with ≥ 2 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo. The Ishak scoring system is used to grade fibrosis in the histology samples. The Ishak system (0 through 6 scale) was developed to grade portal-based liver fibrosis associated with viral hepatitis: 0: No fibrosis 1. Fibrous expansion of some portal areas, with or without short fibrous septa 2. Fibrous expansion of most portal areas, with or without short fibrous septa 3. Fibrous expansion of most portal areas with occasional portal to portal bridging 4. Fibrous expansion of portal areas with marked bridging (portal to portal as well as portal to central) 5. Marked bridging (portal-portal and/or portal-central) with occasional nodules (incomplete cirrhosis) 6. Cirrhosis, probable or definite
Outcome measures
| Measure |
BMS-986263 45 mg QW (Once Weekly)
n=18 Participants
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
n=28 Participants
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
n=15 Participants
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
|---|---|---|---|
|
The Number of Participants With ≥ 2 Stage Improvement in Liver Fibrosis (Ishak Score) After 12 Weeks of Treatment
|
0 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and day 85Population: Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment
The number of participants with ≥ 15% decrease from baseline in liver stiffness is used to asses the effects of treatment compared to placebo Magnetic resonance elastography (MRE) is a noninvasive medical imaging technique that quantitatively measures the stiffness of soft tissues by introducing shear waves and imaging their propagation using magnetic resonance imaging (MRI). MRE will be used to quantitate liver stiffness as a surrogate biomarker of liver fibrosis.
Outcome measures
| Measure |
BMS-986263 45 mg QW (Once Weekly)
n=18 Participants
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
n=28 Participants
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
n=15 Participants
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
|---|---|---|---|
|
The Number of Participants With ≥ 15% Decrease From Baseline in Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) at Day 85
|
4 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and day 85Population: Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment
Change from baseline in liver stiffness is used to asses the effects of treatment compared to placebo. Magnetic resonance elastography (MRE) is a noninvasive medical imaging technique that quantitatively measures the stiffness of soft tissues by introducing shear waves and imaging their propagation using magnetic resonance imaging (MRI). MRE will be used to quantitate liver stiffness as a surrogate biomarker of liver fibrosis
Outcome measures
| Measure |
BMS-986263 45 mg QW (Once Weekly)
n=18 Participants
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
n=28 Participants
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
n=15 Participants
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
|---|---|---|---|
|
Change From Baseline in Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) Day 85
|
-0.162 Change in kPa
Standard Deviation 0.5807
|
-0.064 Change in kPa
Standard Deviation 0.7384
|
-0.049 Change in kPa
Standard Deviation 0.5801
|
Adverse Events
BMS-986263 45 mg QW (Once Weekly)
BMS-986263 90 mg QW (Once Weekly)
Placebo QW (Once Weekly)
Serious adverse events
| Measure |
BMS-986263 45 mg QW (Once Weekly)
n=18 participants at risk
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
n=28 participants at risk
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
n=15 participants at risk
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
3.6%
1/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
Other adverse events
| Measure |
BMS-986263 45 mg QW (Once Weekly)
n=18 participants at risk
BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
BMS-986263 90 mg QW (Once Weekly)
n=28 participants at risk
BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
Placebo QW (Once Weekly)
n=15 participants at risk
Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
6.7%
1/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Endocrine disorders
Hypothyroidism
|
5.6%
1/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
6.7%
1/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
6.7%
1/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
General disorders
Fatigue
|
0.00%
0/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
6.7%
1/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
6.7%
1/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
3.6%
1/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
6.7%
1/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
5.6%
1/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
6/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
53.6%
15/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
6.7%
1/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
7.1%
2/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
13.3%
2/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
6.7%
1/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.6%
1/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
3.6%
1/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
6.7%
1/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Psychiatric disorders
Abulia
|
5.6%
1/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
0.00%
0/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/18 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
3.6%
1/28 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
6.7%
1/15 • From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
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