Trial Outcomes & Findings for Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT01246063)

NCT ID: NCT01246063

Last Updated: 2019-04-08

Results Overview

* MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level. * Please note that the maximum tolerated dose of carfilzomib and pegylated liposomal doxorubicin was not reached. The data below is the recommended dosage for further studies.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

40 participants

Primary outcome timeframe

28 days (completion of first cycle of all Phase I - Part 1 patients)

Results posted on

2019-04-08

Participant Flow

The study opened to participant enrollment on 05/14/2012 and closed to participant enrollment on 08/02/2016.

Participant milestones

Participant milestones
Measure
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Overall Study
STARTED
3
4
4
5
7
17
Overall Study
COMPLETED
3
4
4
5
7
17
Overall Study
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
n=3 Participants
Dose Level 0: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (27 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
n=4 Participants
Dose Level 1: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (36 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
n=4 Participants
Dose Level 2: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (45 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
n=5 Participants
Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
n=7 Participants
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
n=17 Participants
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Total
n=40 Participants
Total of all reporting groups
Region of Enrollment
United States
3 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
5 Participants
n=4 Participants
7 Participants
n=21 Participants
17 Participants
n=10 Participants
40 Participants
n=115 Participants
Age, Continuous
65 years
n=5 Participants
66.5 years
n=7 Participants
72 years
n=5 Participants
57 years
n=4 Participants
63 years
n=21 Participants
65 years
n=10 Participants
65 years
n=115 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
5 Participants
n=4 Participants
5 Participants
n=21 Participants
7 Participants
n=10 Participants
23 Participants
n=115 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
2 Participants
n=21 Participants
10 Participants
n=10 Participants
17 Participants
n=115 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
4 Participants
n=4 Participants
7 Participants
n=21 Participants
17 Participants
n=10 Participants
37 Participants
n=115 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
3 Participants
n=115 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
5 Participants
n=10 Participants
9 Participants
n=115 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
4 Participants
n=4 Participants
7 Participants
n=21 Participants
11 Participants
n=10 Participants
30 Participants
n=115 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=10 Participants
1 Participants
n=115 Participants

PRIMARY outcome

Timeframe: 28 days (completion of first cycle of all Phase I - Part 1 patients)

Population: Participants enrolled in the Phase I - Part 1 portion of this study were the only evaluable participants for this outcome measure.

* MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level. * Please note that the maximum tolerated dose of carfilzomib and pegylated liposomal doxorubicin was not reached. The data below is the recommended dosage for further studies.

Outcome measures

Outcome measures
Measure
Phase I - Part 1
n=16 Participants
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 2
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Maximum Tolerated Dose (MTD) of Carfilzomib and Pegylated Liposomal Doxorubicin (Phase I - Part 1).
Carfilzomib Recommended Dose
56 mg/m^2
Maximum Tolerated Dose (MTD) of Carfilzomib and Pegylated Liposomal Doxorubicin (Phase I - Part 1).
Pegylated liposomal doxorubicin recommended dose
30 mg/m^2

PRIMARY outcome

Timeframe: 28 days (completion of first cycle of all Phase I - Part 2 patients)

Population: Participants enrolled in the Phase I - Part 2 portion of this study were the only evaluable participants for this outcome measure.

-MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.

Outcome measures

Outcome measures
Measure
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 2
n=7 Participants
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Maximum Tolerated Dose (MTD) of Carfilzomib and PLD (Phase I - Part 2).
Carfilzomib dose
56 mg/m^2
Maximum Tolerated Dose (MTD) of Carfilzomib and PLD (Phase I - Part 2).
Pegylated liposomal doxorubicin dose
30 mg/m^2

PRIMARY outcome

Timeframe: 28 days (completion of first cycle of all Phase I - Part 2 patients)

Population: Participants enrolled in the Phase I - Part 2 portion of this study were the only evaluable participants for this outcome measure.

-MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.

Outcome measures

Outcome measures
Measure
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 2
n=7 Participants
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Maximum Tolerated Dose (MTD) of Dexamethasone (Phase I - Part 2).
20 mg

PRIMARY outcome

Timeframe: Completion of treatment (median number of cycles was 9.5 (range 1-34))

Population: For this outcome measure the Phase I - Part 1 Dose Level 3 and Phase I - Part 2 participants were combined with the Phase 2 participants as they received the same dosing of carfilzomib. The remaining Phase I - Part 1 participants were not evaluable for this outcome measure.

-A confirmed response is defined to be a complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG Criteria.

Outcome measures

Outcome measures
Measure
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 2
n=24 Participants
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 - Efficacy of Carfilzomib in Combination With PLD and Dexamethasone as Measured by the Percentage of Participants With Confirmed Tumor Responses
20 Participants

PRIMARY outcome

Timeframe: Through 30 days after completion of treatment (median number of cycles was 9.5 (range 1-34))

Population: For this outcome measure the Phase I - Part 2 participants were combined with the Phase 2 participants as they received the same dosing regimen. Phase I - Part 1 participants were not evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 2
n=24 Participants
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 - Toxicity of Carfilzomib in Combination With PLD and Dexamethasone as Measured by Number of Participants Who Experience Grade 3/4 Toxicity
22 Participants

SECONDARY outcome

Timeframe: Completion of follow-up (median of 23.3 months)

Outcome measures

Outcome measures
Measure
Phase I - Part 1
n=3 Participants
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 2
n=4 Participants
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2
n=4 Participants
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
n=5 Participants
Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
n=7 Participants
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
n=17 Participants
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Median Overall Survival
25.490 months
Interval 0.0 to 60.025
18.780 months
Interval 1.493 to 36.067
11.610 months
Interval 0.0 to 23.889
32.340 months
Interval 0.0 to 86.811
18.720 months
Interval 8.66 to 28.78
NA months
The median overall survival was not reached in the follow-up time period.

SECONDARY outcome

Timeframe: Through completion of follow-up (median follow-up was 23.3 months)

Population: This outcome measure is for Phase 2 (including Phase I Part 2) participants only. Phase I Part 2 and Phase 2 participants who began alternative anti-multiple myeloma treatment prior to progression were censored.

-Progression per IMWG Criteria

Outcome measures

Outcome measures
Measure
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 2
n=8 Participants
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Progression-free Survival Time (Phase 2 Only)
13.4 months
Interval 5.0 to 21.7

SECONDARY outcome

Timeframe: Through completion of follow-up (median follow-up was 23.3 months)

* For participants with confirmed tumor responses * A confirmed response is defined to be a complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG Criteria

Outcome measures

Outcome measures
Measure
Phase I - Part 1
n=1 Participants
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 2
n=2 Participants
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2
n=2 Participants
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
n=4 Participants
Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
n=5 Participants
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
n=15 Participants
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Median Duration of Overall Response
6.090 months
The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates.
6.840 months
The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates.
3.420 months
The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates.
13.130 months
Interval 0.0 to 27.761
9.440 months
Interval 3.58 to 15.3
23.950 months
Interval 14.072 to 33.828

Adverse Events

Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)

Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths

Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)

Serious events: 4 serious events
Other events: 4 other events
Deaths: 2 deaths

Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)

Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths

Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)

Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths

Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)

Serious events: 10 serious events
Other events: 17 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
n=3 participants at risk
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
n=4 participants at risk
Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
n=4 participants at risk
Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
n=5 participants at risk
Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
n=7 participants at risk
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
n=17 participants at risk
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
General disorders
Weakness
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Pain
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Cardiac disorders
Aortic valve disease
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Cardiac disorders
Supraventricular tachycardia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Diarrhea
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Diverticulitis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Fever
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Infusion related reaction
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Acute bronchitis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Pneumonia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
RSV infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Sepsis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Skin infection (cellulitis)
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Skin infection (MRSA)
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Skin infection (shingles)
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Upper respiratory infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
23.5%
4/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Urinary tract infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Injury, poisoning and procedural complications
Polypharmacy
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Left hip pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Acute encephalopathy
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Posterior reversible encephalopathy syndrome
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Acute rental failure
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnea (COPD exacerbation)
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Vascular disorders
Thromboembolic event (DVT)
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.

Other adverse events

Other adverse events
Measure
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
n=3 participants at risk
Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
n=4 participants at risk
Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
n=4 participants at risk
Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
n=5 participants at risk
Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
n=7 participants at risk
Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
n=17 participants at risk
Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Blood and lymphatic system disorders
Anemia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
4/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
85.7%
6/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
82.4%
14/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Blood and lymphatic system disorders
Hemolysis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Blood and lymphatic system disorders
Lymph node swelling
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Cardiac disorders
Heart failure
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Cardiac disorders
Heart murmur
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Cardiac disorders
Myocardial infarction
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Cardiac disorders
Sinus bradycardia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Cardiac disorders
Sinus tachycardia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Cardiac disorders
Tricuspid valve disease
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Ear and labyrinth disorders
Ear pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Ear and labyrinth disorders
Right ear fullness
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Ear and labyrinth disorders
Tinnitus
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Ear and labyrinth disorders
Vertigo
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Eye disorders
Blurred vision
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Eye disorders
Cataract
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
23.5%
4/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Eye disorders
Conjunctivitis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Eye disorders
Dry eye
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Eye disorders
Eye erythema
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Eye disorders
Flashing lights
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Eye disorders
Subconjunctival hemorrhage
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Eye disorders
Watering eyes
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Abdominal distension
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Abdominal pain
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Anal fistula
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Anal pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Bloating
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Constipation
100.0%
3/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
35.3%
6/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Dental caries
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Diarrhea
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
5/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
57.1%
4/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
52.9%
9/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Diverticulitis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Dyspepsia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Dysphagia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Fecal incontinence
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Gastroenteritis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Gastroesophageal reflux disease
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Hemorrhoids
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Hypersalivating
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Ileus
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Indigestion
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Mouth sores
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Mucositits oral
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
35.3%
6/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Nausea
100.0%
3/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
57.1%
4/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
52.9%
9/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Oral dysesthesia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Oral pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Rectal hemorrhage
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Rectal pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Rectal ulcer
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Sores at corner of mouth
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Stomach flu
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Stomach pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Stomach virus
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Toothache
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Upset stomach
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Gastrointestinal disorders
Vomiting
100.0%
3/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
85.7%
6/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
23.5%
4/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Achy
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Black spot-tongue
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Chills
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
23.5%
4/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Edema face
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Edema limbs
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Fatigue
100.0%
3/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
5/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
71.4%
5/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
58.8%
10/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Fever
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
47.1%
8/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Flu Like Symptoms
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Generalized pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Groin pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Hand pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
IV site swelling
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Infusion related reaction
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Infusion site extravasation
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
29.4%
5/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Injection like reaction
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Kidney pain cramping
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Legs/jaw/head pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Localized edema
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
29.4%
5/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Localized edema-feet
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Malaise
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Neck edema
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Night sweats
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Non-cardiac chest pain
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Pain
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Rib cage pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Shoulder blade pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Sweating
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Hepatobiliary disorders
Gallstones
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Anorectal infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Bone infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
C. diff colitis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Conjunctivitis infective
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Finger wart
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Groin infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Lip infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Lung infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Nail infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Oral candidiasis/thrush
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
29.4%
5/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Otitis media
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
General disorders
Pain-head to toe
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Perianal abscess
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Salivary gland infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Sinusitis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
29.4%
5/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Skin infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Stool (+) VRE
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Stool (+) norovirus
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Stye
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Tooth infection
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Upper respiratory infection
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
58.8%
10/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Urinary tract infection
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
23.5%
4/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Infections and infestations
Viral illness
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Injury, poisoning and procedural complications
Bruising
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Injury, poisoning and procedural complications
Elbow wound
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Injury, poisoning and procedural complications
Fall
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Injury, poisoning and procedural complications
Fracture
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Injury, poisoning and procedural complications
Great toe wound
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Injury, poisoning and procedural complications
Phalangeal fracture
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Injury, poisoning and procedural complications
Rib fractures
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Injury, poisoning and procedural complications
Right foot fracture
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Injury, poisoning and procedural complications
Spinal fracture - pathologic
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Alanine aminotransferase increased
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
58.8%
10/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Alkaline phosphatase increased
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Aspartate aminotransferase increased
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
57.1%
4/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
82.4%
14/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Blood bilirubin increased
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
29.4%
5/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
CPK increased
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Cardiac troponin I increased
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Cholesterol high
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Creatinine increased
100.0%
3/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
71.4%
5/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
47.1%
8/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
INR increased
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
35.3%
6/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Lipase increased
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Lymphocyte count decreased
100.0%
3/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
7/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
17/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Lymphocyte count increased
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Neutrophil count decreased
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
85.7%
6/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
70.6%
12/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Platelet count decreased
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
5/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
7/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
17/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Serum amylase increased
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Weight gain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
Weight loss
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
29.4%
5/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Investigations
White blood cell decreased
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
71.4%
5/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
17/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Anorexia
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
35.3%
6/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Diabetes type 2
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hypercalcemia
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
52.9%
9/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hyperglycemia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hyperkalemia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
41.2%
7/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hypermagnesemia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hypernatremia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
47.1%
8/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hyperphosphatemia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
71.4%
5/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
70.6%
12/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hypertriglyceridemia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hyperuricemia
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
52.9%
9/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hypoalbuminemia
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
57.1%
4/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
64.7%
11/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hypocalcemia
100.0%
3/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
4/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
5/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
71.4%
5/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
35.3%
6/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hypoglycemia
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hypokalemia
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
57.1%
4/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
23.5%
4/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hypomagnesemia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hyponatremia
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
47.1%
8/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Hypophosphatemia
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
70.6%
12/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Metabolism and nutrition disorders
Iron overload
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Achiness hips
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Back pain
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Body aches
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Bone pain
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Buttock pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Cramping arms, hands, and feet
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Cramping hands and feet
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Elbow pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Flank pain
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Foot pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Hip pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Hip/leg pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Intercostal pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Joint range of motion decreased in lumbar spine
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Leg cramps
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Muscle cramps/spasms
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Muscle spasms-hands
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Muscle weakness-hands
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Muscle weakness/heaviness lower limbs
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Osteonecrosis of palate
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Pain in extremity
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Rib pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Right armpit pain
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Right rib cage pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Right side pain with deep breath
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Rotator cuff tear full/partial
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Shoulder pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Shoulder spasm
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Warm spot on thigh
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Musculoskeletal and connective tissue disorders
Wrist pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BCCA Nasal Ala
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Enlarging pulmonary nodule
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T10 lesion-invasion into spinal cord
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Akathisia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Dizziness
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
29.4%
5/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Dysgeusia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Facial droop
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Fingertip sensitivity
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Headache
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
57.1%
4/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
47.1%
8/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Intracranial hemorrhage
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Lethargy
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Memory impairment
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Neuralgia-shingles pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Paresthesia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Peripheral sensory neuropathy
100.0%
3/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Sinus pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Spasticity
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Syncope
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Tingling/numbness lower jaw
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Nervous system disorders
Tremor
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Psychiatric disorders
Agitation
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Psychiatric disorders
Anxiety
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Psychiatric disorders
Concentration impairment
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Psychiatric disorders
Confusion
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
23.5%
4/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Psychiatric disorders
Delirium
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Psychiatric disorders
Hallucinations
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Psychiatric disorders
Insomnia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
52.9%
9/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
ATN
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Acute kidney injury
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Bladder pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Cystitis noninfective
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Dysuria
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Hematuria
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Proteinuria
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Urinary frequency
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Urinary incontinence
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Urinary retention
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Renal and urinary disorders
Urinary urgency
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Reproductive system and breast disorders
Scrotal pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Reproductive system and breast disorders
Vaginal hemorrhage
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Congestion head/chest
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
75.0%
3/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
80.0%
4/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
58.8%
10/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Dypnea
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
100.0%
4/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
57.1%
4/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
47.1%
8/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Epistaxis
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Hypoxia
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Indeterminate lung nodules
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Postnasal drip
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
42.9%
3/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
52.9%
9/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Respiratory distress-tachypnea
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Sore throat
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
23.5%
4/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
"Pink Areas" palms of hands
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Blood blisters
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Bug bites
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Cat bite
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Enlarging mole
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Erythema Multiforme
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Erythematous rash
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Flaking skin on hands
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Foot blisters (after excessive walking)
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Head nodule
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Nail changes
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Open area-left eyebrow
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
33.3%
1/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Periorbital edema
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
11.8%
2/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Petechial rash
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Poison ivy
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Pressure ulcers - buttocks
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
28.6%
2/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Rash aceniform
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Rash arms
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Rash-back
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Skin blisters s/p lesion removal
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Skin tear
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Skin ulceration
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Skin and subcutaneous tissue disorders
Swelling from bug bites
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Surgical and medical procedures
Colonoscopy
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Surgical and medical procedures
Cytoscopy with bladder biopsies
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Surgical and medical procedures
Excision osteonecrosis-maxilla
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Surgical and medical procedures
Foot surgery
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Surgical and medical procedures
Shoulder rotator cuff repair-right
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Surgical and medical procedures
Urethral sling placement
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Vascular disorders
Flushing
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Vascular disorders
Flushing-face
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Vascular disorders
Hot flashes
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
20.0%
1/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
5.9%
1/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Vascular disorders
Hypertension
66.7%
2/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
60.0%
3/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
35.3%
6/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Vascular disorders
Hypotension
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
50.0%
2/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
40.0%
2/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
17.6%
3/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Vascular disorders
Thromboembolic event - DVT
0.00%
0/3 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
25.0%
1/4 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
0.00%
0/5 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
14.3%
1/7 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
23.5%
4/17 • Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.

Additional Information

Ravi Vij, M.D.

Washington University School of Medicine

Phone: 314-454-8304

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place