Trial Outcomes & Findings for Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors (NCT NCT01214668)

Last Updated: 2019-01-04

Results Overview

Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which is corrected for the participant's predose albumin to identify the albumin-corrected exposure range of LY 573636 when combined with liposomal doxorubicin. MTD is the highest dose with \<33% of participants having a dose-limiting toxicity (DLT) in the first 28-day cycle of treatment. DLT is an adverse event (AE) that is likely related to the study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity; Gr 3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments. Those who enter the study with Gr 2 hepatic enzyme abnormalities, DLT for an isolated Gr 3 hepatic enzyme abnormality is determined by investigators; a DLT can be declared if a participant experiences increasing toxicity during treatment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

Predose up to 28 days postdose in Cycle 1

Results posted on

2019-01-04

Participant Flow

The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have "completed" the trial if they experienced progressive disease or an adverse event.

Participant milestones

Participant milestones
Measure	LY 300 μg/mL + Dox LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).
Overall Study STARTED	4	3	6	6	6	6
Overall Study Received at Least One Dose of Study Drug	4	3	6	6	6	6
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	3	6	6	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	LY 300 μg/mL + Dox LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).
Overall Study Adverse Event	0	1	0	2	1	1
Overall Study Death	0	0	1	0	0	0
Overall Study Progressive Disease	4	2	5	4	4	5
Overall Study Withdrawal by Subject	0	0	0	0	1	0

Baseline Characteristics

Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LY 300 μg/mL + Dox n=4 Participants LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox n=3 Participants LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox n=6 Participants LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\μg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).	Total n=31 Participants Total of all reporting groups
Age, Continuous	57.39 years STANDARD_DEVIATION 13.60 • n=5 Participants	51.54 years STANDARD_DEVIATION 8.55 • n=7 Participants	64.65 years STANDARD_DEVIATION 7.53 • n=5 Participants	58.57 years STANDARD_DEVIATION 2.71 • n=4 Participants	52.24 years STANDARD_DEVIATION 15.08 • n=21 Participants	57.82 years STANDARD_DEVIATION 12.97 • n=10 Participants	57.54 years STANDARD_DEVIATION 10.93 • n=115 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	28 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	25 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 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	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) White	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	28 Participants n=115 Participants
Race (NIH/OMB) More than one race	1 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	1 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	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	4 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	31 Participants n=115 Participants

PRIMARY outcome

Timeframe: Predose up to 28 days postdose in Cycle 1

Population: All participants who received at least one dose of the study drug.

Outcome measures

Outcome measures
Measure	LY 300 μg/mL + Dox n=4 Participants LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox n=3 Participants LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox n=6 Participants LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).
Recommended Phase 2 Dose	NA micrograms per milliliter (μg/mL) MTD was not reached because none of the participants reached the criteria for MTD.	NA micrograms per milliliter (μg/mL) MTD was not reached because none of the participants reached the criteria for MTD.	NA micrograms per milliliter (μg/mL) MTD was not reached because none of the participants reached the criteria for MTD.	NA micrograms per milliliter (μg/mL) MTD was not reached because none of the participants reached the criteria for MTD.	NA micrograms per milliliter (μg/mL) MTD was not reached because none of the participants reached the criteria for MTD.	NA micrograms per milliliter (μg/mL) MTD was not reached because none of the participants reached the criteria for MTD.

SECONDARY outcome

Timeframe: Baseline to study completion up to 18.49 months

Population: All participants who received at least one dose of the study drug.

Clinically significant events are defined as serious adverse events (SAEs), regardless of causality, during the study including the 30-day follow-up period. A summary of SAEs and other nonserious adverse events is located in the Reported Adverse Event section. Death due to progressive disease was not considered as an SAE.

Outcome measures

Outcome measures
Measure	LY 300 μg/mL + Dox n=4 Participants LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox n=3 Participants LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox n=6 Participants LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).
Number of Participants With Clinically Significant Events	2 Participants	0 Participants	5 Participants	3 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Predose, 30 minutes (min), 2 hours (h), 4 h, 166 h, 360 h and 698 h postdose in Cycle 1; Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 2; Predose, 166h, 360h and 698 h postdose in Cycle 3

Population: Participants who received the study drug and had sufficient pharmacokinetic (PK) data to estimate Cmax at the specified time points.

Outcome measures

Outcome measures
Measure	LY 300 μg/mL + Dox n=31 Participants LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 Cycle 1	335.1 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 13.9	—	—	—	—	—
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 Cycle 2	284.5 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 15.9	—	—	—	—	—
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 Cycle 3	250.7 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 25.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to measured progressive disease up to 4.7 months

Population: All participants who received at least one dose of the study drug.

Number of participants with tumor response = number of participants with complete response (CR) + number of participants with partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in the sum of longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	LY 300 μg/mL + Dox n=4 Participants LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox n=3 Participants LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox n=6 Participants LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).
Number of Participants With Tumor Response	1 Participants	0 Participants	1 Participants	3 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 1; Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 2; Predose, 166h, 360h and 698 h postdose in Cycle 3

Population: Participants who received the study drug and had sufficient pharmacokinetic (PK) data to calculate AUCalb at the specified time points.

LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636.

Outcome measures

Outcome measures
Measure	LY 300 μg/mL + Dox n=31 Participants LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).
Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb) Cycle 3	228.4 hourmicrograms per milliliter (hµg/mL) Geometric Coefficient of Variation 323.3	—	—	—	—	—
Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb) Cycle 1	1081.0 hourmicrograms per milliliter (hµg/mL) Geometric Coefficient of Variation 163.9	—	—	—	—	—
Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb) Cycle 2	413.7 hourmicrograms per milliliter (hµg/mL) Geometric Coefficient of Variation 684.3	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of randomization until up to 30 days post study treatment discontinuation, assessed up to 4.7 months

Population: All participants who received at least one dose of the study drug.

Outcome measures

Outcome measures
Measure	LY 300 μg/mL + Dox n=4 Participants LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox n=3 Participants LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox n=6 Participants LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox n=6 Participants LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).
Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

Adverse Events

LY 300 μg/mL + Dox

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

LY 320 μg/mL + Dox

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

LY 340 μg/mL + Dox

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

LY 360 μg/mL + Dox

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

LY 380 μg/mL + Dox

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

LY Albumin and Day 15 PK Tailored + Dox

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LY 300 μg/mL + Dox n=4 participants at risk LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox n=3 participants at risk LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox n=6 participants at risk LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox n=6 participants at risk LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox n=6 participants at risk LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox n=6 participants at risk LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Neutropenia	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Thrombocytopenia	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Cardiac disorders Cardiac arrest	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Ear and labyrinth disorders Vertigo	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Constipation	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Dysphagia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Large intestinal obstruction	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Nausea	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Oesophagitis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Stomatitis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Vomiting	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Mucosal inflammation	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Hepatobiliary disorders Dilatation intrahepatic duct acquired	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Immune system disorders Drug hypersensitivity	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations H1n1 influenza	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Postoperative wound infection	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Sepsis syndrome	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Wound infection	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Investigations Blood creatinine increased	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Investigations White blood cell count decreased	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypokalaemia	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Nervous system disorders Vocal cord paralysis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Psychiatric disorders Confusional state	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Vascular disorders Hypotension	25.0% 1/4 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.

Other adverse events

Other adverse events
Measure	LY 300 μg/mL + Dox n=4 participants at risk LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.	LY 320 μg/mL + Dox n=3 participants at risk LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 340 μg/mL + Dox n=6 participants at risk LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 360 μg/mL + Dox n=6 participants at risk LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY 380 μg/mL + Dox n=6 participants at risk LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.	LY Albumin and Day 15 PK Tailored + Dox n=6 participants at risk LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour\micrograms per milliliter (h\µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic \[PK\]) (LY Albumin and Day 15 PK Tailored).
Nervous system disorders Paraesthesia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Nervous system disorders Sedation	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Nervous system disorders Tremor	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Psychiatric disorders Anxiety	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Nervous system disorders Hypoaesthesia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Nervous system disorders Neuropathy peripheral	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Psychiatric disorders Depression	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Nervous system disorders Ataxia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Nervous system disorders Dysgeusia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Nervous system disorders Headache	50.0% 2/4 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 4/6 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 4/6 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Muscular weakness	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	50.0% 2/4 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Anaemia	50.0% 2/4 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 4/6 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Cardiac disorders Cardiac failure congestive	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Cardiac disorders Palpitations	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Cardiac disorders Pericardial effusion	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Cardiac disorders Sinus tachycardia	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Ear and labyrinth disorders Deafness	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Ear and labyrinth disorders Ear discomfort	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Ear and labyrinth disorders Ear pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Ear and labyrinth disorders Tinnitus	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Eye disorders Abnormal sensation in eye	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Eye disorders Eye irritation	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Eye disorders Photopsia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Eye disorders Scleral discolouration	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Eye disorders Vision blurred	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Eye disorders Visual impairment	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal pain upper	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Constipation	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Diarrhoea	50.0% 2/4 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	83.3% 5/6 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Dry mouth	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Dysphagia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Faeces hard	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Flatulence	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Gingival bleeding	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Gingival pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Glossodynia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Haematochezia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Lip blister	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Lip ulceration	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Mouth ulceration	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	100.0% 3/3 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Odynophagia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Oesophagitis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Oral pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Proctalgia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Rectal ulcer	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Stomatitis	50.0% 2/4 • Number of events 6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	100.0% 3/3 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 4/6 • Number of events 4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Tongue disorder	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Tongue ulceration	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Gastrointestinal disorders Vomiting	50.0% 2/4 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Asthenia	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Catheter site pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Catheter site swelling	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Chest pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Chills	50.0% 2/4 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Device occlusion	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Early satiety	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Face oedema	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Fatigue	50.0% 2/4 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	83.3% 5/6 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 4/6 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Feeling abnormal	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Generalised oedema	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Infusion site pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Injection site haemorrhage	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Injection site pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Mucosal inflammation	25.0% 1/4 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Non-cardiac chest pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Oedema	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Oedema peripheral	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Pain	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Pyrexia	100.0% 4/4 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
General disorders Thrombosis in device	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Hepatobiliary disorders Gallbladder pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Bronchitis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Candidiasis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Clostridial infection	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Escherichia infection	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Fungal infection	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Gastric infection	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Herpes zoster	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Hordeolum	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Lung infection	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Nasopharyngitis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Oral candidiasis	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Oral herpes	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Pneumonia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Rash pustular	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Sinusitis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Infections and infestations Urinary tract infection	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 4/6 • Number of events 4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Injury, poisoning and procedural complications Contusion	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Injury, poisoning and procedural complications Fall	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Injury, poisoning and procedural complications Laceration	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Injury, poisoning and procedural complications Nail injury	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Injury, poisoning and procedural complications Procedural pain	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Investigations Blood alkaline phosphatase increased	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Investigations Blood creatinine	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Investigations Blood creatinine increased	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Investigations Ejection fraction decreased	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Investigations Haemoglobin decreased	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Investigations Neutrophil count decreased	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Investigations Weight decreased	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 4/6 • Number of events 4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Investigations Weight increased	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypokalaemia	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 4/6 • Number of events 7 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Psychiatric disorders Insomnia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Psychiatric disorders Libido decreased	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Costovertebral angle tenderness	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Dysuria	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Haematuria	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Hydronephrosis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Hypertonic bladder	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Nocturia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Pollakiuria	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Renal failure acute	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Urinary incontinence	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Urinary retention	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Renal and urinary disorders Urine abnormality	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Reproductive system and breast disorders Genital rash	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Reproductive system and breast disorders Pelvic pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Reproductive system and breast disorders Perineal pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Reproductive system and breast disorders Pruritus genital	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Reproductive system and breast disorders Vaginal odour	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 2/4 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 2/4 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Acne	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Alopecia	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 4/6 • Number of events 4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Blister	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Nail discolouration	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 2/3 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 4/6 • Number of events 6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 5 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	66.7% 2/3 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	50.0% 3/6 • Number of events 3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Skin mass	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Surgical and medical procedures Contraceptive diaphragm	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 1/3 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Vascular disorders Flushing	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Vascular disorders Hot flush	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Vascular disorders Hypertension	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	33.3% 2/6 • Number of events 2 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Vascular disorders Hypotension	0.00% 0/4 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	16.7% 1/6 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
Vascular disorders Thrombosis	25.0% 1/4 • Number of events 1 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/3 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.	0.00% 0/6 Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60