Trial Outcomes & Findings for Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment (NCT NCT01949545)

NCT ID: NCT01949545

Last Updated: 2017-05-02

Results Overview

The area under the curve from time zero (defined as the start of carfilzomib infusion) to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 46 participants
• Primary outcome timeframe: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.
• Results posted on: 2017-05-02

Participant Flow

Participants were assigned to 1 of 4 cohorts with varying degrees of hepatic impairment defined by the National Cancer Institute Organ Dysfunction Working Group Criteria (NCI-ODWG) schema for hepatic function. Completed indicates participants who completed the safety follow-up visit 30 days after the last dose of carfilzomib.

Participant milestones

Measure	Normal Hepatic Function Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Overall Study STARTED	11	17	14	4
Overall Study COMPLETED	11	17	14	4
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment

Baseline characteristics by cohort

Measure	Normal Hepatic Function n=11 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=17 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=14 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment n=4 Participants Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Total n=46 Participants Total of all reporting groups
Age, Continuous	68.5 years STANDARD_DEVIATION 8.2 • n=5 Participants	59.5 years STANDARD_DEVIATION 9.1 • n=7 Participants	61.0 years STANDARD_DEVIATION 7.9 • n=5 Participants	56.3 years STANDARD_DEVIATION 10.9 • n=4 Participants	61.8 years STANDARD_DEVIATION 9.3 • n=21 Participants
Age, Customized < 65 years	3 participants n=5 Participants	12 participants n=7 Participants	8 participants n=5 Participants	3 participants n=4 Participants	26 participants n=21 Participants
Age, Customized ≥ 65 years	8 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	1 participants n=4 Participants	20 participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	1 Participants n=4 Participants	28 Participants n=21 Participants
Race/Ethnicity, Customized Black	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized White	11 participants n=5 Participants	13 participants n=7 Participants	13 participants n=5 Participants	4 participants n=4 Participants	41 participants n=21 Participants
Race/Ethnicity, Customized Not reported	0 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants

PRIMARY outcome

Timeframe: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population, defined as participants who received the intended carfilzomib dose (27 or 56 mg/m²) and who had plasma concentration versus time data for the estimation of each pharmacokinetic (PK) parameter by a non-compartmental analysis.

The area under the curve from time zero (defined as the start of carfilzomib infusion) to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 27 mg/m²	378 ng*hr/mL Geometric Coefficient of Variation 40.8	546 ng*hr/mL Geometric Coefficient of Variation 39.2	477 ng*hr/mL Geometric Coefficient of Variation 33.1	—

PRIMARY outcome

Timeframe: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.

Outcome measures

Measure	Normal Hepatic Function n=8 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=12 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 27 mg/m²	348 ng*hr/mL Geometric Coefficient of Variation 35.4	529 ng*hr/mL Geometric Coefficient of Variation 40.3	500 ng*hr/mL Geometric Coefficient of Variation 38.4	—

SECONDARY outcome

Timeframe: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Maximum Plasma Concentration (Cmax) of Carfilzomib 27 mg/m²	932 ng/mL Geometric Coefficient of Variation 58.4	1290 ng/mL Geometric Coefficient of Variation 47.5	1020 ng/mL Geometric Coefficient of Variation 43.7	—

SECONDARY outcome

Timeframe: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 27 mg/m²	0.292 hours Interval 0.25 to 0.5	0.458 hours Interval 0.25 to 0.667	0.483 hours Interval 0.233 to 0.75	—

SECONDARY outcome

Timeframe: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=8 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=12 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Clearance of Carfilzomib 27 mg/m²	157 L/hour Geometric Coefficient of Variation 32.5	86.4 L/hour Geometric Coefficient of Variation 50.9	103 L/hour Geometric Coefficient of Variation 43.9	—

SECONDARY outcome

Timeframe: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=8 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=12 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Terminal Half-life of Carfilzomib 27 mg/m²	0.469 hours Geometric Coefficient of Variation 22.8	0.541 hours Geometric Coefficient of Variation 75.9	0.511 hours Geometric Coefficient of Variation 219.4	—

SECONDARY outcome

Timeframe: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=8 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=12 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Mean Residence Time (MRT) of Carfilzomib 27 mg/m²	0.108 hours Geometric Coefficient of Variation 60.6	0.167 hours Geometric Coefficient of Variation 45.7	0.235 hours Geometric Coefficient of Variation 70.4	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=8 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=12 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Volume of Distribution at Steady State (Vss) of Carfilzomib 27 mg/m²	16.9 liters Geometric Coefficient of Variation 37.0	14.4 liters Geometric Coefficient of Variation 58.1	24.2 liters Geometric Coefficient of Variation 66.0	—

SECONDARY outcome

Timeframe: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

The area under the curve from time zero to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.

Outcome measures

Measure	Normal Hepatic Function n=8 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=8 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=5 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 56 mg/m²	765 ng*hr/mL Geometric Coefficient of Variation 100.5	1107 ng*hr/mL Geometric Coefficient of Variation 73.7	927 ng*hr/mL Geometric Coefficient of Variation 45.8	—

SECONDARY outcome

Timeframe: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.

Outcome measures

Measure	Normal Hepatic Function n=6 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=8 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=5 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 56 mg/m²	609 ng*hr/mL Geometric Coefficient of Variation 99.6	1108 ng*hr/mL Geometric Coefficient of Variation 73.7	929 ng*hr/mL Geometric Coefficient of Variation 46.2	—

SECONDARY outcome

Timeframe: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=8 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=8 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=5 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Maximum Plasma Concentration (Cmax) of Carfilzomib 56 mg/m²	1697 ng/mL Geometric Coefficient of Variation 93.7	2733 ng/mL Geometric Coefficient of Variation 67.0	2119 ng/mL Geometric Coefficient of Variation 47.9	—

SECONDARY outcome

Timeframe: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=8 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=8 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=5 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 56 mg/m²	0.300 hours Interval 0.25 to 0.583	0.408 hours Interval 0.25 to 0.683	0.400 hours Interval 0.25 to 0.583	—

SECONDARY outcome

Timeframe: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=6 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=8 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=5 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Terminal Half-life of Carfilzomib 56 mg/m²	0.508 hours Geometric Coefficient of Variation 54.7	0.621 hours Geometric Coefficient of Variation 47.7	0.740 hours Geometric Coefficient of Variation 137.7	—

SECONDARY outcome

Timeframe: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=6 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=8 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=5 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Clearance of Carfilzomib 56 mg/m²	181 L/hour Geometric Coefficient of Variation 95.9	92.0 L/hour Geometric Coefficient of Variation 77.2	121 L/hour Geometric Coefficient of Variation 43.5	—

SECONDARY outcome

Timeframe: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=6 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=8 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=5 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Mean Residence Time (MRT) of Carfilzomib 56 mg/m²	0.0834 hours Geometric Coefficient of Variation 195.6	0.161 hours Geometric Coefficient of Variation 43.6	0.164 hours Geometric Coefficient of Variation 30.7	—

SECONDARY outcome

Timeframe: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=6 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=8 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=5 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Volume of Distribution at Steady State (Vss) of Carfilzomib 56 mg/m²	15.0 liters Geometric Coefficient of Variation 52.2	14.8 liters Geometric Coefficient of Variation 51.9	19.8 liters Geometric Coefficient of Variation 36.7	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population, defined as all participants who had adequate carfilzomib exposure and plasma concentration versus time data for the estimation of PK parameters by a non-compartmental analysis at each time point.

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-389/M14 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 9, 0	463 ng*hr/mL Geometric Coefficient of Variation 42.5	417 ng*hr/mL Geometric Coefficient of Variation 30.5	385 ng*hr/mL Geometric Coefficient of Variation 26.8	—
Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-389/M14 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	837 ng*hr/mL Geometric Coefficient of Variation 26.8	752 ng*hr/mL Geometric Coefficient of Variation 29.7	786 ng*hr/mL Geometric Coefficient of Variation 20.3	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=4 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=11 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=8 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-389/M14 Cycle 1 Day 16 (27 mg/m²); N = 4, 11, 8, 0	400 ng*hr/mL Geometric Coefficient of Variation 19.3	432 ng*hr/mL Geometric Coefficient of Variation 29.9	437 ng*hr/mL Geometric Coefficient of Variation 32.7	—
Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-389/M14 Cycle 2 Day 1 (56 mg/m²); N = 4, 6, 5, 0	834 ng*hr/mL Geometric Coefficient of Variation 6.3	770 ng*hr/mL Geometric Coefficient of Variation 27.2	843 ng*hr/mL Geometric Coefficient of Variation 22.3	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Maximum Plasma Concentration (Cmax) for Metabolite PR-389/M14 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 9, 0	189 ng/mL Geometric Coefficient of Variation 32.5	198 ng/mL Geometric Coefficient of Variation 22.7	201 ng/mL Geometric Coefficient of Variation 26.5	—
Maximum Plasma Concentration (Cmax) for Metabolite PR-389/M14 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	381 ng/mL Geometric Coefficient of Variation 15.0	345 ng/mL Geometric Coefficient of Variation 25.9	513 ng/mL Geometric Coefficient of Variation 24.3	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-389/M14 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 9, 0	0.867 hours Interval 0.583 to 1.52	0.792 hours Interval 0.633 to 1.5	0.750 hours Interval 0.583 to 1.0	—
Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-389/M14 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	0.842 hours Interval 0.75 to 1.48	0.992 hours Interval 0.75 to 1.6	0.750 hours Interval 0.65 to 0.783	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=4 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=11 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=8 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Terminal Half-life for Metabolite PR-389/M14 Cycle 1 Day 16 (27 mg/m²); N = 4, 11, 8, 0	1.42 hours Geometric Coefficient of Variation 10.3	1.20 hours Geometric Coefficient of Variation 13.7	1.26 hours Geometric Coefficient of Variation 18.0	—
Terminal Half-life for Metabolite PR-389/M14 Cycle 2 Day 1 (56 mg/m²); N = 4, 6, 5, 0	1.32 hours Geometric Coefficient of Variation 15.3	1.30 hours Geometric Coefficient of Variation 16.1	1.07 hours Geometric Coefficient of Variation 13.6	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=4 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=11 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=8 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Mean Residence Time (MRT) for Metabolite PR-389/M14 Cycle 1 Day 16 (27 mg/m²); N = 4, 11, 8, 0	2.42 hours Geometric Coefficient of Variation 11.4	2.13 hours Geometric Coefficient of Variation 12.2	2.14 hours Geometric Coefficient of Variation 16.0	—
Mean Residence Time (MRT) for Metabolite PR-389/M14 Cycle 2 Day 1 (56 mg/m²); N = 4, 6, 5, 0	2.25 hours Geometric Coefficient of Variation 10.8	2.27 hours Geometric Coefficient of Variation 15.8	1.78 hours Geometric Coefficient of Variation 11.2	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-413/M15 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 9, 0	50.1 ng*hr/mL Geometric Coefficient of Variation 39.5	56.7 ng*hr/mL Geometric Coefficient of Variation 33.9	85.5 ng*hr/mL Geometric Coefficient of Variation 36.6	—
Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-413/M15 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	106 ng*hr/mL Geometric Coefficient of Variation 33.7	119 ng*hr/mL Geometric Coefficient of Variation 38.9	173 ng*hr/mL Geometric Coefficient of Variation 17.8	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=13 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=8 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-413/M15 Cycle 1 Day 16 (27 mg/m²); N = 10, 13, 8, 0	56.6 ng*hr/mL Geometric Coefficient of Variation 43.7	60.8 ng*hr/mL Geometric Coefficient of Variation 32.6	92.9 ng*hr/mL Geometric Coefficient of Variation 41.7	—
Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-413/M15 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	116 ng*hr/mL Geometric Coefficient of Variation 36.9	132 ng*hr/mL Geometric Coefficient of Variation 41.0	186 ng*hr/mL Geometric Coefficient of Variation 18.2	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Maximum Plasma Concentration (Cmax) for Metabolite PR-413/M15 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 9, 0	27.8 ng/mL Geometric Coefficient of Variation 30.5	33.9 ng/mL Geometric Coefficient of Variation 30.7	46.3 ng/mL Geometric Coefficient of Variation 26.6	—
Maximum Plasma Concentration (Cmax) for Metabolite PR-413/M15 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	59.4 ng/mL Geometric Coefficient of Variation 27.5	66.0 ng/mL Geometric Coefficient of Variation 37.2	103 ng/mL Geometric Coefficient of Variation 19.5	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-413/M15 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 9, 0	0.750 hours Interval 0.583 to 0.767	0.767 hours Interval 0.583 to 1.0	0.650 hours Interval 0.583 to 1.1	—
Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-413/M15 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	0.717 hours Interval 0.6 to 1.0	0.800 hours Interval 0.467 to 1.08	0.750 hours Interval 0.617 to 0.75	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=13 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=8 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Terminal Half-life for Metabolite PR-413/M15 Cycle 1 Day 16 (27 mg/m²); N = 10, 13, 8, 0	1.34 hours Geometric Coefficient of Variation 18.9	1.25 hours Geometric Coefficient of Variation 13.6	1.23 hours Geometric Coefficient of Variation 17.6	—
Terminal Half-life for Metabolite PR-413/M15 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	1.18 hours Geometric Coefficient of Variation 21.8	1.24 hours Geometric Coefficient of Variation 10.2	1.07 hours Geometric Coefficient of Variation 16.0	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=13 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=8 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Mean Residence Time (MRT) for Metabolite PR-413/M15 Cycle 1 Day 16 (27 mg/m²); N = 10, 13, 8, 0	2.13 hours Geometric Coefficient of Variation 15.8	2.02 hours Geometric Coefficient of Variation 8.8	2.04 hours Geometric Coefficient of Variation 14.6	—
Mean Residence Time (MRT) for Metabolite PR-413/M15 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	1.96 hours Geometric Coefficient of Variation 18.9	2.09 hours Geometric Coefficient of Variation 8.0	1.83 hours Geometric Coefficient of Variation 8.9	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-519/M16 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 9, 0	125 ng*hr/mL Geometric Coefficient of Variation 27.6	136 ng*hr/mL Geometric Coefficient of Variation 45.2	228 ng*hr/mL Geometric Coefficient of Variation 37.3	—
Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-519/M16 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	278 ng*hr/mL Geometric Coefficient of Variation 23.4	311 ng*hr/mL Geometric Coefficient of Variation 42.9	463 ng*hr/mL Geometric Coefficient of Variation 24.5	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=8 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-519/M16 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 8, 0	127 ng*hr/mL Geometric Coefficient of Variation 27.8	138 ng*hr/mL Geometric Coefficient of Variation 44.9	235 ng*hr/mL Geometric Coefficient of Variation 39.4	—
Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-519/M16 Cycle 2 Day 1 (56 mg/m²); N = 7, 8, 5, 0	281 ng*hr/mL Geometric Coefficient of Variation 25.6	314 ng*hr/mL Geometric Coefficient of Variation 42.7	465 ng*hr/mL Geometric Coefficient of Variation 24.4	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Maximum Plasma Concentration (Cmax) for Metabolite PR-519/M16 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 9, 0	145 ng/mL Geometric Coefficient of Variation 30.7	160 ng/mL Geometric Coefficient of Variation 42.0	257 ng/mL Geometric Coefficient of Variation 43.6	—
Maximum Plasma Concentration (Cmax) for Metabolite PR-519/M16 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	314 ng/mL Geometric Coefficient of Variation 33.6	349 ng/mL Geometric Coefficient of Variation 39.5	546 ng/mL Geometric Coefficient of Variation 23.4	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-519/M16 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 9, 0	0.500 hours Interval 0.25 to 0.667	0.600 hours Interval 0.25 to 0.75	0.700 hours Interval 0.583 to 0.85	—
Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-519/M16 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	0.483 hours Interval 0.25 to 0.617	0.592 hours Interval 0.25 to 0.85	0.583 hours Interval 0.467 to 0.65	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=8 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Terminal Half-life for Metabolite PR-519/M16 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 8, 0	0.786 hours Geometric Coefficient of Variation 14.0	0.728 hours Geometric Coefficient of Variation 22.6	0.673 hours Geometric Coefficient of Variation 13.6	—
Terminal Half-life for Metabolite PR-519/M16 Cycle 2 Day 1 (56 mg/m²); N = 7, 8, 5, 0	0.748 hours Geometric Coefficient of Variation 22.2	0.680 hours Geometric Coefficient of Variation 10.7	0.601 hours Geometric Coefficient of Variation 8.2	—

SECONDARY outcome

Timeframe: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.

Population: Pharmacokinetic-evaluable population with data to allow terminal phase characterization

Outcome measures

Measure	Normal Hepatic Function n=10 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=14 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=8 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Mean Residence Time (MRT) for Metabolite PR-519/M16 Cycle 1 Day 16 (27 mg/m²); N = 10, 14, 8, 0	1.01 hours Geometric Coefficient of Variation 11.3	0.961 hours Geometric Coefficient of Variation 29.1	0.994 hours Geometric Coefficient of Variation 13.3	—
Mean Residence Time (MRT) for Metabolite PR-519/M16 Cycle 2 Day 1 (56 mg/m²); N = 8, 8, 5, 0	0.994 hours Geometric Coefficient of Variation 9.0	1.00 hours Geometric Coefficient of Variation 14.2	0.909 hours Geometric Coefficient of Variation 7.8	—

SECONDARY outcome

Timeframe: From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks

Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship.

Adverse events were graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, on a scale from 1 (mild) to 5 (death).

Outcome measures

Measure	Normal Hepatic Function n=11 Participants Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=17 Participants Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=14 Participants Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment n=4 Participants Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Number of Participants With Adverse Events (AEs) Any adverse event	10 participants	17 participants	14 participants	4 participants
Number of Participants With Adverse Events (AEs) Adverse event Grade ≥ 3	7 participants	12 participants	13 participants	3 participants
Number of Participants With Adverse Events (AEs) Serious adverse events	3 participants	10 participants	8 participants	4 participants
Number of Participants With Adverse Events (AEs) Leading to discontinuation of carfilzomib	1 participants	2 participants	4 participants	0 participants
Number of Participants With Adverse Events (AEs) Fatal adverse events	1 participants	4 participants	1 participants	3 participants
Number of Participants With Adverse Events (AEs) Treatment-related adverse events (TRAE)	8 participants	13 participants	12 participants	1 participants
Number of Participants With Adverse Events (AEs) Treatment-related adverse events Grade ≥ 3	2 participants	5 participants	8 participants	0 participants
Number of Participants With Adverse Events (AEs) Treatment-related serious adverse events	0 participants	3 participants	4 participants	0 participants
Number of Participants With Adverse Events (AEs) TRAE leading to discontinuation of carfilzomib	1 participants	0 participants	3 participants	0 participants
Number of Participants With Adverse Events (AEs) Treatment-related fatal adverse events	0 participants	2 participants	0 participants	0 participants

Adverse Events

Normal Hepatic Function

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Mild Hepatic Impairment

Serious events: 10 serious events

Other events: 17 other events

Deaths: 0 deaths

Moderate Hepatic Impairment

Serious events: 8 serious events

Other events: 14 other events

Deaths: 0 deaths

Severe Hepatic Impairment

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Normal Hepatic Function n=11 participants at risk Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=17 participants at risk Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=14 participants at risk Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment n=4 participants at risk Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Blood and lymphatic system disorders Anaemia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Splenic vein occlusion	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Ascites	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	21.4% 3/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric varices haemorrhage	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oral cavity fistula	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Disease progression	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Multi-organ failure	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bacterial sepsis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Biliary sepsis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lower respiratory tract infection	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sepsis	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Septic shock	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral infection	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Alanine aminotransferase increased	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood bilirubin increased	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hepatic encephalopathy	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 2/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Spinal cord compression	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 2/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Deep vein thrombosis	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypotension	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	Normal Hepatic Function n=11 participants at risk Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Mild Hepatic Impairment n=17 participants at risk Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Moderate Hepatic Impairment n=14 participants at risk Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.	Severe Hepatic Impairment n=4 participants at risk Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Platelet count decreased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia	54.5% 6/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	58.8% 10/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	21.4% 3/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 2/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Neutropenia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	28.6% 4/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Left ventricular dysfunction	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tachycardia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Eye discharge	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Lacrimation increased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Ocular icterus	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal distension	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	17.6% 3/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	28.6% 4/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain upper	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Ascites	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	29.4% 5/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	28.6% 4/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	36.4% 4/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	23.5% 4/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	28.6% 4/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dry mouth	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dyspepsia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Faecal incontinence	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrooesophageal reflux disease	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.8% 2/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Hyperchlorhydria	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Melaena	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	27.3% 3/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	29.4% 5/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	35.7% 5/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Retching	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Umbilical hernia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood alkaline phosphatase decreased	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	27.3% 3/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.8% 2/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	21.4% 3/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chills	18.2% 2/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Early satiety	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Face oedema	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	72.7% 8/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	41.2% 7/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	57.1% 8/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders General physical health deterioration	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Infusion site discomfort	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Mucosal inflammation	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Non-cardiac chest pain	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Oedema peripheral	36.4% 4/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.8% 2/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	35.7% 5/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Temperature intolerance	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Thirst	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	17.6% 3/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Candida infection	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cystitis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Liver abscess	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sinusitis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Skin abrasion	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Alanine aminotransferase increased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	29.4% 5/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	28.6% 4/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Ammonia increased	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Aspartate aminotransferase increased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	23.5% 4/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	28.6% 4/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Basophil count increased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood albumin decreased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood alkaline phosphatase increased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood bicarbonate decreased	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood bilirubin increased	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	64.3% 9/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyponatraemia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.8% 2/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood calcium decreased	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood creatinine increased	18.2% 2/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood lactate dehydrogenase increased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood potassium increased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood urea increased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Creatinine renal clearance decreased	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Haematocrit decreased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Haemoglobin decreased	18.2% 2/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Lymphocyte count decreased	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Monocyte count increased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Red blood cell count decreased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Urine output decreased	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Weight decreased	18.2% 2/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.8% 2/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations White blood cell count increased	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Decreased appetite	27.3% 3/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	29.4% 5/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperuricaemia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoalbuminaemia	18.2% 2/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	17.6% 3/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypocalcaemia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypokalaemia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.8% 2/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.8% 2/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Malnutrition	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.8% 2/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Flank pain	18.2% 2/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscular weakness	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	18.2% 2/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	21.4% 3/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness postural	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Encephalopathy	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	27.3% 3/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Lethargy	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	17.6% 3/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Neuropathy peripheral	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Paraesthesia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Restless legs syndrome	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Confusional state	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Insomnia	27.3% 3/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Mental disorder	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Acute kidney injury	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Cystitis noninfective	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal failure	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal pain	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary incontinence	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	23.5% 4/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	27.3% 3/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	23.5% 4/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	21.4% 3/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Hypoxia	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumonitis	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sinus congestion	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.8% 2/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 2/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 1/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin oedema	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Urticaria	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Flushing	0.00% 0/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	18.2% 2/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypotension	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 1/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Orthostatic hypotension	9.1% 1/11 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/17 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/14 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen, Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER