Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis (NCT NCT05064436)

NCT ID: NCT05064436

Last Updated: 2025-04-24

Results Overview

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

From first visit up to 9 days post

Results posted on

2025-04-24

Participant Flow

10 participants randomized and treated

Participant milestones

Participant milestones
Measure	Part A BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Overall Study STARTED	6	4
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Overall Study Other Reasons	1	0

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A n=6 Participants BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg	Total n=10 Participants Total of all reporting groups
Age, Continuous	35.0 Years STANDARD_DEVIATION 12.0 • n=5 Participants	50.8 Years STANDARD_DEVIATION 4.0 • n=7 Participants	41.3 Years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 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	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	5 Participants n=5 Participants	4 Participants n=7 Participants	9 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 visit up to 9 days post

Population: All Treated Participants

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Part A n=6 Participants BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Number of Participants With Adverse Events Based on Severity. Mild	1 Participants	1 Participants
Number of Participants With Adverse Events Based on Severity. Moderate	1 Participants	2 Participants
Number of Participants With Adverse Events Based on Severity. Severe	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first visit up to 9 days post

Population: All Treated Participants

Number of participants with clinically significant changes in electrocardiograms.

Outcome measures

Outcome measures
Measure	Part A n=6 Participants BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Number of Participants With Clinically Significant Changes in Electrocardiograms.	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first visit up to 9 days post

Population: All Treated Participants

Number of participants with clinically significant changes in vital signs.

Outcome measures

Outcome measures
Measure	Part A n=6 Participants BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Number of Participants With Clinically Significant Changes in Vital Signs.	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first visit up to 9 days post

Population: All Treated Participants

Number of participants with clinically significant changes in laboratory values.

Outcome measures

Outcome measures
Measure	Part A n=6 Participants BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Number of Participants With Clinically Significant Changes in Laboratory Values.	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first visit up to 9 days post

Population: All Treated Participants

Number of participants with clinically significant changes in phsyical examinations.

Outcome measures

Outcome measures
Measure	Part A n=6 Participants BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Number of Participants With Clinically Significant Changes in Phsyical Examinations.	2 Participants	3 Participants

PRIMARY outcome

Timeframe: Data Not Collected

Population: Study terminated before data collection for this endpoint occurred.

Number of participants with clinically significant changes in C-SSRS. Columbia-Suicide Severity Rating Scale (C-SSRS). The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome. Data Not Collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 hours

Population: All Treated Population

Measurement and assessment of radiation exposure and absorption of ionizing radiation in body tissue. The Organ Level Internal Dose Assessment (OLINDA) 2.0 software package (Hermes Medical Solutions) was used to estimate the organ and whole-body radiation absorbed doses. OLINDA uses Medical Internal Radiation Dose (MIRD) methodology (Stabin, Sparks, and Crowe 2005). The NURBs ICRP-89 adult male (73 kg) model was used to calculate the referent s-factors (Valentin and Streffer 2002). Tissue weighting factors defined in (ICRP Publication 103, 2007) were used to calculate the whole body effective dose (ED). All other MIRD assumptions about the homogeneity of source organ distribution were employed.

Outcome measures

Outcome measures
Measure	Part A n=5 Participants BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Radiation Dosimetry Calculated From PET-CT Images in Healthy Participants	4.36 uSv/MBq Standard Deviation 0.57	—

PRIMARY outcome

Timeframe: 90 Mins

Population: All Treated Population

Period of time required to collect the imaging data during a scan. Participants received a bolus intravenous administration of up to 370 MBq of 11CBMS- 986196. Immediately following the 11C-BMS-986196 administration, dynamic PET emission data were acquired for 90 minutes in a single bed position focused on the cranium. For PET acquisitions, a low dose CT scan was performed before administration of the radiotracer, to enable correction for attenuation of emitted radiation.

Outcome measures

Outcome measures
Measure	Part A n=5 Participants BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Image Acquisition Window After Tracer Administration	90 Mins Interval 0.0 to 90.0	90 Mins Interval 0.0 to 90.0

PRIMARY outcome

Timeframe: 2 hours

Population: Response-Evaluable Population with MS, 0 participants in Part A had MS

Standardized uptake value (SUV) is Semi-quantitative measurement of tracer uptake in body tissue defined as ratio of radioactivity per unit volume of a region of interest to the radioactivity per unit volume of the whole body. Test-retest repeatability based on standardized uptake value (SUV) of CNS PET images in participants with MS: The test-retest repeatability will be based on a quantitative analysis of cranial PET images and will be evaluated for the Response-Evaluable 3 population. The test-retest repeatability (%), which is defined based upon the absolute value of the difference between test and retest values normalized by their mean: Test-Retest difference = RT-T Test-retest repeatability (%) = 100%-2×\|(RT-T)/(RT+T)\|×100% with T being the calculated value for the parameter measured at Visit 1 (test, T) and RT being the calculated value for the same parameter measured at Visit 2 (retest, RT).

Outcome measures

Outcome measures
Measure	Part A BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=3 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Percentage of Participants With Test Repeatablity Based on SUV. Cerebral Cortex-Grey Matter	—	96.601 percentage Standard Deviation 3.675
Percentage of Participants With Test Repeatablity Based on SUV. Brain-Grey Matter	—	96.163 percentage Standard Deviation 3.621
Percentage of Participants With Test Repeatablity Based on SUV. Brain-Lesion	—	95.930 percentage Standard Deviation 3.427
Percentage of Participants With Test Repeatablity Based on SUV. Brain-White Matter	—	96.128 percentage Standard Deviation 3.670
Percentage of Participants With Test Repeatablity Based on SUV. Cerebellum-Grey Matter	—	95.114 percentage Standard Deviation 3.557
Percentage of Participants With Test Repeatablity Based on SUV. Cerebellum-White Matter	—	93.541 percentage Standard Deviation 6.164
Percentage of Participants With Test Repeatablity Based on SUV. Cerebral Cortex-White Matter	—	96.697 percentage Standard Deviation 3.571
Percentage of Participants With Test Repeatablity Based on SUV. Cerebral Subcortex-Grey Matter	—	95.833 percentage Standard Deviation 2.957
Percentage of Participants With Test Repeatablity Based on SUV. Cerebral White Matter-White Matter	—	95.912 percentage Standard Deviation 3.893

PRIMARY outcome

Timeframe: 2 Hours

Population: Response-Evaluable Population 3 with MS, 0 participants in Part A had MS

Volume of Distribution (VT) is the ratio of the radioligand concentration in a region of interest to the radioligand concentration in plasma at equilibrium. Test-retest repeatability based on VT of CNS PET images in participants with MS: The test-retest repeatability will be based on a quantitative analysis of cranial PET images and will be evaluated for the Response-Evaluable 3 population. The test-retest repeatability (%), which is defined based upon the absolute value of the difference between test and retest values normalized by their mean: Test-Retest difference = RT-T Test-retest repeatability (%) = 100%-2×\|(RT-T)/(RT+T)\|×100% with T being the calculated value for the parameter measured at Visit 1 (test, T) and RT being the calculated value for the same parameter measured at Visit 2 (retest, RT).

Outcome measures

Outcome measures
Measure	Part A BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Percentage of Participants With Test Repeatablity Based on VT. Brain-Lesion	—	73.396 percentage Standard Deviation 6.751
Percentage of Participants With Test Repeatablity Based on VT. Brain-Grey Matter	—	88.339 percentage Standard Deviation 10.476
Percentage of Participants With Test Repeatablity Based on VT. Brain-White Matter	—	85.514 percentage Standard Deviation 8.202
Percentage of Participants With Test Repeatablity Based on VT. Cerebellum-Grey Matter	—	88.486 percentage Standard Deviation 9.884
Percentage of Participants With Test Repeatablity Based on VT. Cerebellum-White Matter	—	85.167 percentage Standard Deviation 11.593
Percentage of Participants With Test Repeatablity Based on VT. Cerebral Cortex-Grey Matter	—	88.114 percentage Standard Deviation 9.931
Percentage of Participants With Test Repeatablity Based on VT. Cerebral Cortex-White Matter	—	87.262 percentage Standard Deviation 9.439
Percentage of Participants With Test Repeatablity Based on VT. Cerebral Subcortex-Grey Matter	—	83.233 percentage Standard Deviation 9.408
Percentage of Participants With Test Repeatablity Based on VT. Cerebral White Matter-White Matter	—	79.804 percentage Standard Deviation 8.192

PRIMARY outcome

Timeframe: Data Not Collected

Population: Study Terminated, data collection for endpoint did not occur.

Percentage of free brain Burtons Tyrosine Kinase (BTK) relative to baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)

Population: Response-Evaluable 2 Population

Standardized uptake value (SUV) is Semi-quantitative measurement of tracer uptake in body tissue defined as ratio of radioactivity per unit volume of a region of interest to the radioactivity per unit volume of the whole body.

Outcome measures

Outcome measures
Measure	Part A n=5 Participants BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Mean Standardized Uptake Value (SUV) in the Brain Cerebellum-Grey Matter at visit 1	—	0.817 g/mL Standard Deviation 0.099
Mean Standardized Uptake Value (SUV) in the Brain Brain-Lesion at visit 2	—	0.623 g/mL Standard Deviation 0.132
Mean Standardized Uptake Value (SUV) in the Brain Brain-White Matter at visit 2	0.590 g/mL Standard Deviation 0.108	0.705 g/mL Standard Deviation 0.122
Mean Standardized Uptake Value (SUV) in the Brain Brain-White Matter at visit 1	—	0.767 g/mL Standard Deviation 0.098
Mean Standardized Uptake Value (SUV) in the Brain Brain-Grey Matter at visit 1	—	0.773 g/mL Standard Deviation 0.101
Mean Standardized Uptake Value (SUV) in the Brain Brain-Grey Matter at visit 2	0.606 g/mL Standard Deviation 0.121	0.713 g/mL Standard Deviation 0.122
Mean Standardized Uptake Value (SUV) in the Brain Brain-Lesion at visit 1	—	0.677 g/mL Standard Deviation 0.103
Mean Standardized Uptake Value (SUV) in the Brain Cerebellum-Grey Matter at visit 2	0.656 g/mL Standard Deviation 0.135	0.755 g/mL Standard Deviation 0.126
Mean Standardized Uptake Value (SUV) in the Brain Cerebellum-White Matter at visit 1	—	0.857 g/mL Standard Deviation 0.099
Mean Standardized Uptake Value (SUV) in the Brain Cerebellum-White Matter at visit 2	0.672 g/mL Standard Deviation 0.134	0.780 g/mL Standard Deviation 0.136
Mean Standardized Uptake Value (SUV) in the Brain Cerebral Cortex-Grey Matter at visit 1	—	0.763 g/mL Standard Deviation 0.101
Mean Standardized Uptake Value (SUV) in the Brain Cerebral Cortex-Grey Matter at visit 2	0.596 g/mL Standard Deviation 0.121	0.705 g/mL Standard Deviation 0.122
Mean Standardized Uptake Value (SUV) in the Brain Cerebral Cortex-White Matter at visit 1	—	0.783 g/mL Standard Deviation 0.101
Mean Standardized Uptake Value (SUV) in the Brain Cerebral Cortex-White Matter at visit 2	0.606 g/mL Standard Deviation 0.118	0.725 g/mL Standard Deviation 0.122
Mean Standardized Uptake Value (SUV) in the Brain Cerebral Subcortex-Grey Matter at visit 1	—	0.797 g/mL Standard Deviation 0.155
Mean Standardized Uptake Value (SUV) in the Brain Cerebral Subcortex-Grey Matter at visit 2	0.674 g/mL Standard Deviation 0.122	0.745 g/mL Standard Deviation 0.159
Mean Standardized Uptake Value (SUV) in the Brain Cerebral White Matter-White Matter at visit 1	—	0.723 g/mL Standard Deviation 0.084
Mean Standardized Uptake Value (SUV) in the Brain Cerebral White Matter-White Matte at visit 2	0.550 g/mL Standard Deviation 0.096	0.658 g/mL Standard Deviation 0.118

PRIMARY outcome

Timeframe: On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)

Population: Response-Evaluable 2 Population

Volume of Distribution (VT) is the ratio of the radioligand concentration in a region of interest to the radioligand concentration in plasma at equilibrium.

Outcome measures

Outcome measures
Measure	Part A n=5 Participants BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 Participants BMS-986196 Approximately 370 MBq, equivalent to up to 20 μg
Mean Volume of Distribution (VT) in the Brain Cerebral White Matter-White Matte at visit 2	2.675 mL/cm³ Standard Deviation 0.496	2.665 mL/cm³ Standard Deviation 0.712
Mean Volume of Distribution (VT) in the Brain Brain-Grey Matter at visit 1	—	2.378 mL/cm³ Standard Deviation 0.213
Mean Volume of Distribution (VT) in the Brain Brain-Grey Matter at visit 2	2.498 mL/cm³ Standard Deviation 0.343	2.505 mL/cm³ Standard Deviation 0.604
Mean Volume of Distribution (VT) in the Brain Brain-Lesion at visit 1	—	2.805 mL/cm³ Standard Deviation 0.680
Mean Volume of Distribution (VT) in the Brain Brain-Lesion at visit 2	—	3.095 mL/cm³ Standard Deviation 1.407
Mean Volume of Distribution (VT) in the Brain Brain-White Matter at visit 1	—	2.608 mL/cm³ Standard Deviation 0.374
Mean Volume of Distribution (VT) in the Brain Brain-White Matter at visit 2	2.645 mL/cm³ Standard Deviation 0.417	2.660 mL/cm³ Standard Deviation 0.677
Mean Volume of Distribution (VT) in the Brain Cerebellum-Grey Matter at visit 1	—	2.535 mL/cm³ Standard Deviation 0.219
Mean Volume of Distribution (VT) in the Brain Cerebellum-Grey Matter at visit 2	2.715 mL/cm³ Standard Deviation 0.356	2.638 mL/cm³ Standard Deviation 0.639
Mean Volume of Distribution (VT) in the Brain Cerebellum-White Matter at visit 1	—	2.883 mL/cm³ Standard Deviation 0.427
Mean Volume of Distribution (VT) in the Brain Cerebellum-White Matter at visit 2	2.953 mL/cm³ Standard Deviation 0.350	2.903 mL/cm³ Standard Deviation 0.822
Mean Volume of Distribution (VT) in the Brain Cerebral Cortex-Grey Matter at visit 1	—	2.340 mL/cm³ Standard Deviation 0.198
Mean Volume of Distribution (VT) in the Brain Cerebral Cortex-Grey Matter at visit 2	2.453 mL/cm³ Standard Deviation 0.338	2.470 mL/cm³ Standard Deviation 0.578
Mean Volume of Distribution (VT) in the Brain Cerebral Cortex-White Matter at visit 1	—	2.540 mL/cm³ Standard Deviation 0.294
Mean Volume of Distribution (VT) in the Brain Cerebral Cortex-White Matter at visit 2	2.645 mL/cm³ Standard Deviation 0.390	2.680 mL/cm³ Standard Deviation 0.660
Mean Volume of Distribution (VT) in the Brain Cerebral Subcortex-Grey Matter at visit 1	—	2.445 mL/cm³ Standard Deviation 0.315
Mean Volume of Distribution (VT) in the Brain Cerebral Subcortex-Grey Matter at visit 2	2.645 mL/cm³ Standard Deviation 0.404	2.710 mL/cm³ Standard Deviation 0.815
Mean Volume of Distribution (VT) in the Brain Cerebral White Matter-White Matter at visit 1	—	2.790 mL/cm³ Standard Deviation 0.613

Adverse Events

Part A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part B

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A n=6 participants at risk BMS-986196 Approximately 370MBq, equivalent to up to 20 μg	Part B n=4 participants at risk BMS-986196 Approximately 370MBq, equivalent to up to 20 μg
Gastrointestinal disorders Nausea	0.00% 0/6 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	25.0% 1/4 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Fatigue	16.7% 1/6 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	25.0% 1/4 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	25.0% 1/4 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Procedural pain	16.7% 1/6 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/4 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Vascular access site bruising	0.00% 0/6 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	25.0% 1/4 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Syncope	16.7% 1/6 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/4 • Adverse Events and Serious Adverse Events: Approximately up to 11 days All-Cause mortality (From randomization to end of study): Approximately up to 11 days The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: 1-855-907-3286

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