Trial Outcomes & Findings for A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors (NCT NCT00886782)

NCT ID: NCT00886782

Last Updated: 2023-04-28

Results Overview

DLT is defined based on adverse events that are deemed to be drug-related and occur during the first cycle of therapy using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: Up to 28 days
• Results posted on: 2023-04-28

Participant Flow

Participant milestones

Measure	BMS-863233 25 mg BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Overall Study STARTED	3	3	5
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	3	3	5

Reasons for withdrawal

Measure	BMS-863233 25 mg BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Overall Study Disease progression	3	3	3
Overall Study Study drug toxicity	0	0	1
Overall Study Adverse event unrelated to Study drug	0	0	1

Baseline Characteristics

A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

Baseline characteristics by cohort

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	Total n=11 Participants Total of all reporting groups
Age, Continuous	56.0 Years STANDARD_DEVIATION 14.73 • n=5 Participants	61.0 Years STANDARD_DEVIATION 13.08 • n=7 Participants	61.8 Years STANDARD_DEVIATION 7.60 • n=5 Participants	60.0 Years STANDARD_DEVIATION 10.36 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 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	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 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	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: All treated participants

DLT is defined based on adverse events that are deemed to be drug-related and occur during the first cycle of therapy using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Outcome measures

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Number of Participants With Dose Limiting Toxicities (DLTs) of BMS-863233	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days post last dose (Up to 14 months)

Population: All treated participants

Number of participants with any grade adverse events (AEs), any grade drug-related AEs, any grade serious adverse events (SAEs), any grade drug-related SAEs, and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Number of Participants With Adverse Events (AEs) AEs	3 Participants	3 Participants	5 Participants
Number of Participants With Adverse Events (AEs) Drug-related AEs	1 Participants	0 Participants	4 Participants
Number of Participants With Adverse Events (AEs) SAEs	1 Participants	1 Participants	4 Participants
Number of Participants With Adverse Events (AEs) Drug-related SAEs	0 Participants	0 Participants	2 Participants
Number of Participants With Adverse Events (AEs) AEs leading to discontinuation	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days post last dose (Up to 14 months)

Population: All treated participants

Number of participants who died due to any cause.

Outcome measures

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Number of Participants Who Died	0 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days post last dose (Up to 14 months)

Population: All treated participants

Number of participants with lab abnormalities grade 3-4 including hematology, chemistry, coagulation, liver and kidney function, and electrolytes using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Grade 3 = severe Grade 4 = very severe

Outcome measures

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Number of Participants With Lab Abnormalities Grade 3-4 Hematology: Hemoglobin, low	0 Participants	0 Participants	1 Participants
Number of Participants With Lab Abnormalities Grade 3-4 Hematology: Platelet Count, low	0 Participants	0 Participants	1 Participants
Number of Participants With Lab Abnormalities Grade 3-4 Hematology: Lymphocytes, low	0 Participants	0 Participants	1 Participants
Number of Participants With Lab Abnormalities Grade 3-4 Coagulation	0 Participants	0 Participants	0 Participants
Number of Participants With Lab Abnormalities Grade 3-4 Liver and Kidney Function	0 Participants	0 Participants	1 Participants
Number of Participants With Lab Abnormalities Grade 3-4 Electrolytes: Hyponatremia, low	1 Participants	0 Participants	1 Participants
Number of Participants With Lab Abnormalities Grade 3-4 Electrolytes: Phosphorus, low	0 Participants	0 Participants	1 Participants
Number of Participants With Lab Abnormalities Grade 3-4 Other Chemistry Testing	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

Population: All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data

BMS-863233 maximum observed plasma concentration (Cmax) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.

Outcome measures

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
BMS-863233 Maximum Observed Plasma Concentration (Cmax) Day 1	904.550 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 8.638	2654.930 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 35.913	5993.514 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 50.036
BMS-863233 Maximum Observed Plasma Concentration (Cmax) Day 14	907.695 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 58.219	1688.018 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 86.384	2870.897 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 37.996

SECONDARY outcome

Timeframe: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

Population: All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data

BMS-863233 time of maximum observed plasma concentration (Tmax) is derived from plasma concentration versus time data.

Outcome measures

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
BMS-863233 Time of Maximum Observed Plasma Concentration (Tmax) Day 1	0.567 Hours Interval 0.5 to 1.0	0.500 Hours Interval 0.5 to 2.07	1.000 Hours Interval 0.5 to 2.03
BMS-863233 Time of Maximum Observed Plasma Concentration (Tmax) Day 14	2.000 Hours Interval 0.63 to 2.03	2.000 Hours Interval 0.5 to 2.0	2.042 Hours Interval 2.0 to 2.08

SECONDARY outcome

Timeframe: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

Population: All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data

BMS-863233 Area under the concentration-time curve in one dosing interval (AUC(TAU)) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.

Outcome measures

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
BMS-863233 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) Day 1	2317.310 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40.781	8301.889 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 18.311	22289.734 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 63.942
BMS-863233 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) Day 14	2395.319 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 105.616	8067.026 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 57.866	19372.627 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 105.004

SECONDARY outcome

Timeframe: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

Population: All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data

BMS-863233 clearance (CL) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.

Outcome measures

Measure	BMS-863233 25 mg n=2 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=2 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
BMS-863233 Clearance (CL) Day 14	173.950 mL/min Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 105.616	103.301 mL/min Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 43.840	86.032 mL/min Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 105.004

SECONDARY outcome

Timeframe: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 36-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

Population: All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data

Effective elimination half-life (T-HALFeff) is derived from plasma concentration versus time data.

Outcome measures

Measure	BMS-863233 25 mg n=2 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=2 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
BMS-863233 Effective Elimination Half-Life (T-HALFeff) Day 14	2.640 Hours Interval 1.11 to 4.17	4.282 Hours Interval 3.13 to 5.16	18.866 Hours Interval 2.31 to 35.42

SECONDARY outcome

Timeframe: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

Population: All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data

BMS-863233 accumulation index (AI_AUC) is derived from plasma concentration versus time data. AI is calculated based on ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.

Outcome measures

Measure	BMS-863233 25 mg n=2 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=2 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
BMS-863233 Accumulation Index (AI_AUC) Day 14	1.099 Ratio Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 67.737	0.972 Ratio Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 45.006	1.053 Ratio Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 45.084

SECONDARY outcome

Timeframe: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 24-hours end-of-infusion on Cycle 1 Day 2 (C1D2), (C1D7, or D8, or D9), and C1D14

Population: All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data

BMS-863233 trough observed plasma concentration (Ctrough) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.

Outcome measures

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=4 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
BMS-863233 Trough Observed Plasma Concentration (Ctrough) C1D2 predose	5.000 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 0	7.626 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 79.551	88.313 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 114.753
BMS-863233 Trough Observed Plasma Concentration (Ctrough) C1D7, or D8, or D9 predose	—	10.068 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 47.910	51.789 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 166.529
BMS-863233 Trough Observed Plasma Concentration (Ctrough) C1D14 predose	8.803 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 103.533	11.703 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 54.957	130.302 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 135.793
BMS-863233 Trough Observed Plasma Concentration (Ctrough) C1D14 24hr postdose	8.463 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 97.338	14.844 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 87.332	34.001 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 171.563

SECONDARY outcome

Timeframe: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C3D1, C4D1, C1D2, C1D15, C3D15,

Population: All treated participants with baseline measurements

Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

Outcome measures

Measure	BMS-863233 25 mg n=2 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 2 hours post dose C1D1	3.5 Beats/min Standard Deviation 2.12	0 Beats/min Standard Deviation 7.81	-1.4 Beats/min Standard Deviation 4.10
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 4 hours post dose C1D1	8.0 Beats/min Standard Deviation 11.31	3.0 Beats/min Standard Deviation 12.73	-1.0 Beats/min Standard Deviation 7.62
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 8 hours post dose C1D1	7.5 Beats/min Standard Deviation 4.95	3.7 Beats/min Standard Deviation 5.51	4.3 Beats/min Standard Deviation 6.99
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 24 hours post dose C1D2	7.5 Beats/min Standard Deviation 3.54	-4.7 Beats/min Standard Deviation 8.33	1.0 Beats/min Standard Deviation 13.00
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate Predose C1D15	-2.5 Beats/min Standard Deviation 4.95	-0.7 Beats/min Standard Deviation 5.13	—
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 2 hours post dose C1D15	2.5 Beats/min Standard Deviation 4.95	0 Beats/min Standard Deviation 6.56	2.5 Beats/min Standard Deviation 3.54
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 4 hours post dose C1D15	8.0 Beats/min Standard Deviation 12.73	5.7 Beats/min Standard Deviation 7.09	9.0 Beats/min Standard Deviation 2.83
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 8 hours post dose C1D15	11.5 Beats/min Standard Deviation 3.54	10.0 Beats/min Standard Deviation 8.19	3.5 Beats/min Standard Deviation 0.71
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 24 hours post dose C1D15	11.5 Beats/min Standard Deviation 2.12	-0.7 Beats/min Standard Deviation 6.03	2.0 Beats/min Standard Deviation 6.82
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 2 hours post dose C3D1	-2.0 Beats/min Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 4 hours post dose C3D1	3.0 Beats/min Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 8 hours post dose C3D1	12.0 Beats/min Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 24 hours post dose C3D1	-1.0 Beats/min Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	2.3 Beats/min Standard Deviation 5.13
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate Predose C3D15	-3.0 Beats/min Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 2 hours post dose C3D15	-7.0 Beats/min Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 4 hours post dose C3D15	-4.0 Beats/min Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 8 hours post dose C3D15	-1.0 Beats/min Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 24 hours post dose C3D15	-2.0 Beats/min Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate 24 hours post dose C4D1	—	—	8.3 Beats/min Standard Deviation 5.86

SECONDARY outcome

Timeframe: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1

Population: All treated participants with baseline measurements

Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

Outcome measures

Measure	BMS-863233 25 mg n=2 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 2 hours post dose C1D1	9.0 msec Standard Deviation 4.24	-11.3 msec Standard Deviation 21.20	1.6 msec Standard Deviation 4.34
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 4 hours post dose C1D1	6.0 msec Standard Deviation 11.31	2.0 msec Standard Deviation 11.31	3.6 msec Standard Deviation 6.99
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 8 hours post dose C1D1	8.0 msec Standard Deviation 11.31	-2.7 msec Standard Deviation 18.58	-2.0 msec Standard Deviation 8.79
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 24 hours post dose C1D2	4.0 msec Standard Deviation 8.49	4.0 msec Standard Deviation 10.39	2.7 msec Standard Deviation 6.11
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval Predose C1D15	0 msec Standard Deviation 0	1.3 msec Standard Deviation 3.06	—
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 2 hours post dose C1D15	-3.0 msec Standard Deviation 4.24	0.7 msec Standard Deviation 6.11	-2.0 msec Standard Deviation 2.83
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 4 hours post dose C1D15	7.0 msec Standard Deviation 12.73	3.3 msec Standard Deviation 7.57	-3.0 msec Standard Deviation 1.41
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 8 hours post dose C1D15	-1.0 msec Standard Deviation 1.41	2.7 msec Standard Deviation 12.22	-2.0 msec Standard Deviation 2.83
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 24 hours post dose C1D15	-5.0 msec Standard Deviation 1.41	-4.7 msec Standard Deviation 12.22	-4.0 msec Standard Deviation 7.21
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 2 hours post dose C3D1	4.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 4 hours post dose C3D1	8.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 8 hours post dose C3D1	0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 24 hours post dose C3D1	18.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	-6.7 msec Standard Deviation 7.57
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval Predose C3D15	-20.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 2 hours post dose C3D15	20.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 4 hours post dose C3D15	-14.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 8 hours post dose C3D15	4.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 24 hours post dose C3D15	8.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval 24 hours post dose C4D1	—	—	-12.7 msec Standard Deviation 3.06

SECONDARY outcome

Timeframe: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1

Population: All treated participants with baseline measurements

Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

Outcome measures

Measure	BMS-863233 25 mg n=2 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 24 hours post dose C1D15	1.0 msec Standard Deviation 4.24	4.0 msec Standard Deviation 5.29	3.6 msec Standard Deviation 7.13
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 2 hours post dose C3D1	0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 4 hours post dose C3D1	-6.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 8 hours post dose C3D1	-4.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 24 hours post dose C3D1	0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	-13.3 msec Standard Deviation 8.33
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval Predose C3D15	-6.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 2 hours post dose C3D15	-2.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 4 hours post dose C3D15	-4.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 8 hours post dose C3D15	-6.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 24 hours post dose C3D15	-8.0 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 24 hours post dose C4D1	—	—	-8.7 msec Standard Deviation 7.02
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 2 hours post dose C1D1	-5.0 msec Standard Deviation 1.41	0 msec Standard Deviation 0	3.2 msec Standard Deviation 6.26
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 4 hours post dose C1D1	-2.0 msec Standard Deviation 2.83	0 msec Standard Deviation 0	1.6 msec Standard Deviation 8.76
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 8 hours post dose C1D1	-1.0 msec Standard Deviation 1.41	5.3 msec Standard Deviation 11.02	0.5 msec Standard Deviation 6.61
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 24 hours post dose C1D2	-2.0 msec Standard Deviation 5.66	3.3 msec Standard Deviation 4.16	-0.7 msec Standard Deviation 14.47
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval Predose C1D15	1.0 msec Standard Deviation 1.41	4.0 msec Standard Deviation 7.21	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 2 hours post dose C1D15	-1.0 msec Standard Deviation 1.41	4.7 msec Standard Deviation 6.43	-4.0 msec Standard Deviation 11.31
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 4 hours post dose C1D15	0 msec Standard Deviation 2.83	8.0 msec Standard Deviation 6.00	6.0 msec Standard Deviation 2.83
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval 8 hours post dose C1D15	0 msec Standard Deviation 0	-1.3 msec Standard Deviation 1.15	4.0 msec Standard Deviation 5.66

SECONDARY outcome

Timeframe: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1

Population: All treated participants with baseline measurements

Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

Outcome measures

Measure	BMS-863233 25 mg n=2 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 24 hours post dose C1D15	-16.9 msec Standard Deviation 13.77	5.9 msec Standard Deviation 13.89	-5.6 msec Standard Deviation 6.99
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 24 hours post dose C3D1	0.4 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	-15.4 msec Standard Deviation 9.40
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval Predose C3D15	-3.1 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 2 hours post dose C3D15	16.7 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 2 hours post dose C1D1	-8.4 msec Standard Deviation 3.57	5.8 msec Standard Deviation 8.23	-4.8 msec Standard Deviation 11.62
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 4 hours post dose C1D1	-18.0 msec Standard Deviation 0.68	2.0 msec Standard Deviation 3.42	-9.8 msec Standard Deviation 7.03
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 8 hours post dose C1D1	-16.0 msec Standard Deviation 10.38	11.9 msec Standard Deviation 16.50	-13.2 msec Standard Deviation 14.26
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 24 hours post dose C1D2	-3.8 msec Standard Deviation 4.47	3.6 msec Standard Deviation 5.43	-19.1 msec Standard Deviation 10.02
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval Predose C1D15	5.0 msec Standard Deviation 0.60	4.2 msec Standard Deviation 7.38	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 2 hours post dose C1D15	-16.3 msec Standard Deviation 2.83	7.2 msec Standard Deviation 8.22	0.6 msec Standard Deviation 7.91
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 4 hours post dose C1D15	-17.4 msec Standard Deviation 3.81	8.1 msec Standard Deviation 6.14	4.6 msec Standard Deviation 9.45
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 8 hours post dose C1D15	-20.5 msec Standard Deviation 19.44	3.1 msec Standard Deviation 10.47	1.5 msec Standard Deviation 1.20
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 2 hours post dose C3D1	11.4 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 4 hours post dose C3D1	-3.6 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 8 hours post dose C3D1	8.5 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 4 hours post dose C3D15	9.9 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 8 hours post dose C3D15	-1.7 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 24 hours post dose C3D15	0.8 msec Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval 24 hours post dose C4D1	—	—	3.0 msec Standard Deviation 4.48

SECONDARY outcome

Timeframe: From first dose up to 14 months

Population: All treated participants

ORR is defined as the total percentage of participants whose best response is either a complete response (CR) or a partial response (PR) defined by the RECIST criteria.

CR= Complete disappearance of all tumor lesions. PR= Decrease, relative to baseline, of 30% or greater in the sum of the longest diameter of all "target" lesions.

Outcome measures

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Objective Response Rate (ORR)	0.0 Perentage of participants Interval 0.0 to 70.8	0.0 Perentage of participants Interval 0.0 to 70.8	0.0 Perentage of participants Interval 0.0 to 52.2

SECONDARY outcome

Timeframe: From first dose up to 14 months

Population: All treated participants

DCR is defined as the total percentage of participants whose best response is complete response (CR), partial response (PR), or ≥ 4 months stable disease (SD) defined by the RECIST criteria.

CR= Complete disappearance of all tumor lesions. PR= Decrease, relative to baseline, of 30% or greater in the sum of the longest diameter of all "target" lesions.

SD= Failure to meet criteria for complete or partial response, in the absence of progressive disease.

Outcome measures

Measure	BMS-863233 25 mg n=3 Participants BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 Participants BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 Participants BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Disease Control Rate (DCR)	33.3 Perentage of participants Interval 0.8 to 90.6	0.0 Perentage of participants Interval 0.0 to 70.8	40.0 Perentage of participants Interval 5.3 to 85.3

Adverse Events

BMS-863233 25 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

BMS-863233 50 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

BMS-863233 100 mg

Serious events: 4 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Measure	BMS-863233 25 mg n=3 participants at risk BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 participants at risk BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 participants at risk BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders DYSPHAGIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
General disorders LOCALISED OEDEMA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
General disorders PYREXIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Infections and infestations BACTERAEMIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM PROGRESSION	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	40.0% 2/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Nervous system disorders SPINAL CORD COMPRESSION	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).

Other adverse events

Measure	BMS-863233 25 mg n=3 participants at risk BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 50 mg n=3 participants at risk BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator	BMS-863233 100 mg n=5 participants at risk BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator
Blood and lymphatic system disorders ANAEMIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	40.0% 2/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Eye disorders VISION BLURRED	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	40.0% 2/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders ABDOMINAL TENDERNESS	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders CONSTIPATION	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders DIARRHOEA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	66.7% 2/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	40.0% 2/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders DYSPHAGIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders FAECAL INCONTINENCE	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders NAUSEA	100.0% 3/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	80.0% 4/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders PROCTALGIA	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Gastrointestinal disorders VOMITING	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	80.0% 4/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
General disorders FATIGUE	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	60.0% 3/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Infections and infestations INFLUENZA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Infections and infestations NASOPHARYNGITIS	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Infections and infestations PNEUMONIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Infections and infestations RHINITIS	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Investigations BLOOD CREATININE	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Investigations WEIGHT DECREASED	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	40.0% 2/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Metabolism and nutrition disorders DEHYDRATION	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Metabolism and nutrition disorders HYPERCALCAEMIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Metabolism and nutrition disorders HYPERGLYCAEMIA	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Metabolism and nutrition disorders HYPOGLYCAEMIA	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Metabolism and nutrition disorders HYPOKALAEMIA	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Metabolism and nutrition disorders HYPOMAGNESAEMIA	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Musculoskeletal and connective tissue disorders ARTHRALGIA	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Nervous system disorders CAUDA EQUINA SYNDROME	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Nervous system disorders CEREBRAL ISCHAEMIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Nervous system disorders DIZZINESS	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	40.0% 2/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Nervous system disorders HEADACHE	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Nervous system disorders NEUROPATHY PERIPHERAL	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Nervous system disorders SPINAL CORD COMPRESSION	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Psychiatric disorders DEPRESSION	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Psychiatric disorders INSOMNIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Renal and urinary disorders DYSURIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Renal and urinary disorders POLLAKIURIA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Renal and urinary disorders PROTEINURIA	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	33.3% 1/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Respiratory, thoracic and mediastinal disorders WHEEZING	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Skin and subcutaneous tissue disorders GENERALISED ERYTHEMA	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Vascular disorders FLUSHING	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	0.00% 0/3 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).	20.0% 1/5 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: Clinical.Trials@bms.com

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