Trial Outcomes & Findings for A Study of Chemotherapy Treatment for Patients With Ovarian Cancer (NCT NCT00428610)

NCT ID: NCT00428610

Last Updated: 2018-04-19

Results Overview

Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 103 participants
• Primary outcome timeframe: Baseline to measured progressive disease up to 12.68 months
• Results posted on: 2018-04-19

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

Measure	Target Cmax 420 µg/mL Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Overall Study STARTED	53	18	32
Overall Study Received at Least One Dose of Study Drug	53	18	32
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	53	18	32

Reasons for withdrawal

Measure	Target Cmax 420 µg/mL Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Overall Study Death Due to Adverse Event	3	0	5
Overall Study Death Due to Progressive Disease	0	0	2
Overall Study Adverse Event	2	3	2
Overall Study Investigator Decision	2	1	1
Overall Study Progressive Disease	42	14	22
Overall Study Withdrawal by Subject	4	0	0

Baseline Characteristics

A Study of Chemotherapy Treatment for Patients With Ovarian Cancer

Baseline characteristics by cohort

Measure	Target Cmax 420 µg/mL n=53 Participants Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=18 Participants Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=32 Participants The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.	Total n=103 Participants Total of all reporting groups
Age, Continuous	56.88 years STANDARD_DEVIATION 11.12 • n=5 Participants	59.88 years STANDARD_DEVIATION 8.98 • n=7 Participants	56.83 years STANDARD_DEVIATION 10.37 • n=5 Participants	57.39 years STANDARD_DEVIATION 10.51 • n=4 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants	103 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized African Decent (black)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	50 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants	99 Participants n=4 Participants
Race/Ethnicity, Customized East Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	32 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants	63 Participants n=4 Participants
Region of Enrollment Russia	12 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment Italy	9 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	28 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to measured progressive disease up to 12.68 months

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

Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.

Outcome measures

Measure	Target Cmax 420 µg/mL n=53 Participants Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=18 Participants Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=32 Participants The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Percentage of Participants With Complete Response and Partial Response (Objective Response Rate)	7.5 percentage of participants Interval 1.6 to 13.5	0 percentage of participants No participant had CR or PR, therefore 90% Confidence Interval was not calculable.	3.1 percentage of participants Interval 0.0 to 8.2

SECONDARY outcome

Timeframe: Baseline to measured progressive disease or death due to any cause up to 21.26 months

Population: All participants who received at least 1 dose of the study drug.

Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

Outcome measures

Measure	Target Cmax 420 µg/mL n=53 Participants Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=18 Participants Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=32 Participants The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Progression Free Survival	1.87 months Interval 1.41 to 3.02	2.40 months Interval 1.61 to 3.35	2.10 months Interval 1.87 to 3.22

SECONDARY outcome

Timeframe: Baseline to measured progressive disease up to 21.26 months

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

Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated multiplied by 100.

Outcome measures

Measure	Target Cmax 420 µg/mL n=53 Participants Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=18 Participants Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=32 Participants The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate)	45.3 percentage of participants Interval 34.0 to 56.5	61.1 percentage of participants Interval 42.2 to 80.0	34.4 percentage of participants Interval 20.6 to 48.2

SECONDARY outcome

Timeframe: Predose up to 2 hours postdose in Cycles 1 and 2

Population: All participants who received at least one dose of the study drug and had pharmacokinetics data at the specified time points.

Outcome measures

Measure	Target Cmax 420 µg/mL n=51 Participants Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=17 Participants Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=32 Participants The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 Cycle 1	368.4 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 8.9	324.1 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 7.9	340.9 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 15.4
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 Cycle 2	323.0 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 13.6	326.1 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 14.5	320.7 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 17.7

SECONDARY outcome

Timeframe: First treatment to death due to any cause up to 42.91 months

Population: All participants who received at least one dose of the study drug. The numbers of participants censored are 11 (Target Cmax 420 µg/mL group), 6 (Target Cmax 360 µg/mL group) and 14 (Albumin-Tailored Dose group).

Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact.

Outcome measures

Measure	Target Cmax 420 µg/mL n=53 Participants Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=18 Participants Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=32 Participants The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Overall Survival	13.08 months Interval 7.66 to 21.36	10.09 months Interval 8.02 to 22.97	11.63 months Interval 7.2 to The upper limit of the 90% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: Time of response to time of measured progressive disease up to 12.68 months

Population: All participants who received at least one dose of the study drug and had complete response (CR) or partial response (PR).

The duration of response (complete response [CR] or partial response [PR]) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.

Outcome measures

Measure	Target Cmax 420 µg/mL n=4 Participants Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=1 Participants The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Duration of Response	5.03 months Interval 2.99 to 6.21	—	12.68 months Only 1 participant had PR, therefore 90% Confidence Interval was not calculable.

SECONDARY outcome

Timeframe: Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months

Population: All participants who received at least one dose of the study drug and stable disease or better.

Duration of stable disease is defined from date of documented stable disease (SD) or better to first date of progressive disease or death from any cause (assessed every cycle during study therapy, or every 2 months during post-therapy until disease progression or death). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

Outcome measures

Measure	Target Cmax 420 µg/mL n=24 Participants Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=11 Participants Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=11 Participants The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Duration of Stable Disease	3.71 months Interval 2.76 to 4.21	3.27 months Interval 2.79 to 10.02	3.78 months Interval 3.22 to 5.59

SECONDARY outcome

Timeframe: First treatment dose up to 43.91 months

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

Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.

Outcome measures

Measure	Target Cmax 420 µg/mL n=53 Participants Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=18 Participants Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=32 Participants The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Number of Participants With Adverse Events (Safety) Serious Adverse Events	21 Participants	5 Participants	15 Participants
Number of Participants With Adverse Events (Safety) Other Nonserious Adverse Events	47 Participants	18 Participants	30 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Study treatment discontinuation up to 30 days post study treatment discontinuation

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

Outcome measures

Measure	Target Cmax 420 µg/mL n=53 Participants Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=18 Participants Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=32 Participants The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment	2 Participants	3 Participants	1 Participants

Adverse Events

Target Cmax 420 µg/mL

Serious events: 21 serious events

Other events: 47 other events

Deaths: 0 deaths

Target Cmax 360 μg/mL

Serious events: 5 serious events

Other events: 18 other events

Deaths: 0 deaths

Albumin-Tailored Dose

Serious events: 15 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Target Cmax 420 µg/mL n=53 participants at risk Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=18 participants at risk Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=32 participants at risk The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Blood and lymphatic system disorders Anaemia	9.4% 5/53 • Number of events 7 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	12.5% 4/32 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Febrile neutropenia	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Leukopenia	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Neutropenia	7.5% 4/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	15.6% 5/32 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Thrombocytopenia	13.2% 7/53 • Number of events 7 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	21.9% 7/32 • Number of events 7 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Cardiac disorders Atrial fibrillation	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Cardiac disorders Atrial flutter	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Cardiac disorders Bradycardia	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Cardiac disorders Cardiac failure	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Cardiac disorders Pericardial effusion	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Cardiac disorders Sinus tachycardia	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal pain	7.5% 4/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal pain upper	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Ascites	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Constipation	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Gastric ulcer	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Intestinal obstruction	3.8% 2/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Nausea	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Small intestinal obstruction	3.8% 2/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	12.5% 4/32 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Vomiting	5.7% 3/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
General disorders Hyperpyrexia	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Hepatobiliary disorders Cholecystitis	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Immune system disorders Drug hypersensitivity	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Abscess intestinal	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Cellulitis	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Clostridium difficile colitis	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Device related infection	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Empyema	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Herpes zoster	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Pneumonia	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Sepsis	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Septic shock	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Staphylococcal sepsis	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Urinary tract infection	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Urosepsis	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Ejection fraction decreased	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Dehydration	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypokalaemia	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypomagnesaemia	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hyponatraemia	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Renal and urinary disorders Renal failure acute	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Vascular disorders Hypertension	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Vascular disorders Hypotension	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.

Other adverse events

Measure	Target Cmax 420 µg/mL n=53 participants at risk Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Target Cmax 360 μg/mL n=18 participants at risk Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.	Albumin-Tailored Dose n=32 participants at risk The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms/milliliter (h\*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
Blood and lymphatic system disorders Anaemia	18.9% 10/53 • Number of events 13 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	27.8% 5/18 • Number of events 6 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	12.5% 4/32 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Leukopenia	7.5% 4/53 • Number of events 7 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Neutropenia	22.6% 12/53 • Number of events 17 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Blood and lymphatic system disorders Thrombocytopenia	34.0% 18/53 • Number of events 28 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	22.2% 4/18 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Cardiac disorders Palpitations	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Cardiac disorders Sinus tachycardia	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Cardiac disorders Tachycardia	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Ear and labyrinth disorders Ear pain	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Eye disorders Vision blurred	7.5% 4/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal distension	7.5% 4/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal mass	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal pain	18.9% 10/53 • Number of events 12 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	15.6% 5/32 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal pain lower	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	16.7% 3/18 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Abdominal pain upper	7.5% 4/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Ascites	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Constipation	13.2% 7/53 • Number of events 7 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	18.8% 6/32 • Number of events 6 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Diarrhoea	22.6% 12/53 • Number of events 17 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	38.9% 7/18 • Number of events 10 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	21.9% 7/32 • Number of events 8 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Dyspepsia	5.7% 3/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	12.5% 4/32 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Dysphagia	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Gastritis	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Nausea	30.2% 16/53 • Number of events 20 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	22.2% 4/18 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	37.5% 12/32 • Number of events 14 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Stomatitis	11.3% 6/53 • Number of events 8 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	21.9% 7/32 • Number of events 7 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Tongue ulceration	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Gastrointestinal disorders Vomiting	9.4% 5/53 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	22.2% 4/18 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	21.9% 7/32 • Number of events 8 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
General disorders Asthenia	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	22.2% 4/18 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	21.9% 7/32 • Number of events 7 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
General disorders Chills	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
General disorders Early satiety	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
General disorders Fatigue	47.2% 25/53 • Number of events 43 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	27.8% 5/18 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	12.5% 4/32 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
General disorders Injection site pain	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
General disorders Malaise	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
General disorders Oedema peripheral	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
General disorders Pain	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
General disorders Pyrexia	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Device related infection	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Ear infection	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Ear lobe infection	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Herpes zoster	7.5% 4/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Influenza	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Postoperative wound infection	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Sinusitis	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Upper respiratory tract infection	7.5% 4/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Infections and infestations Urinary tract infection	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Alanine aminotransferase increased	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Aspartate aminotransferase increased	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Blood alkaline phosphatase increased	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Blood creatinine increased	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	16.7% 3/18 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Body temperature	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Haemoglobin decreased	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	12.5% 4/32 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Neutrophil count decreased	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Platelet count decreased	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Weight decreased	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations Weight increased	3.8% 2/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Investigations White blood cell count decreased	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Decreased appetite	9.4% 5/53 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	18.8% 6/32 • Number of events 8 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Dehydration	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypoalbuminaemia	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypocalcaemia	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypokalaemia	15.1% 8/53 • Number of events 8 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	15.6% 5/32 • Number of events 6 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hypomagnesaemia	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	12.5% 4/32 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Hyponatraemia	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Metabolism and nutrition disorders Obesity	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Back pain	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 3/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Nervous system disorders Dizziness	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Nervous system disorders Dysgeusia	7.5% 4/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Nervous system disorders Headache	15.1% 8/53 • Number of events 8 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Nervous system disorders Neuropathy peripheral	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Nervous system disorders Paraesthesia	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	22.2% 4/18 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Nervous system disorders Post herpetic neuralgia	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Psychiatric disorders Anxiety	11.3% 6/53 • Number of events 6 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Psychiatric disorders Confusional state	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Psychiatric disorders Depression	7.5% 4/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Psychiatric disorders Insomnia	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Renal and urinary disorders Dysuria	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Renal and urinary disorders Haematuria	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Renal and urinary disorders Nephrolithiasis	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Renal and urinary disorders Nocturia	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Renal and urinary disorders Urinary incontinence	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	7.5% 4/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	15.6% 5/32 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	11.1% 2/18 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	15.6% 5/32 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.7% 3/53 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.7% 3/53 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Alopecia	18.9% 10/53 • Number of events 10 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	15.6% 5/32 • Number of events 5 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Dry skin	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Pruritus	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	16.7% 3/18 • Number of events 3 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	6.2% 2/32 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Skin and subcutaneous tissue disorders Rash	26.4% 14/53 • Number of events 25 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/18 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	9.4% 3/32 • Number of events 4 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Vascular disorders Hypotension	3.8% 2/53 • Number of events 2 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	3.1% 1/32 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Vascular disorders Lymphoedema	1.9% 1/53 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Vascular disorders Raynaud's phenomenon	0.00% 0/53 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	5.6% 1/18 • Number of events 1 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.	0.00% 0/32 Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during 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