Trial Outcomes & Findings for Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors (NCT NCT01831089)

Last Updated: 2020-04-10

Results Overview

The MTD will be the lowest level at which one third or more evaluable patients experience a DLT in Cycle 1. DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

69 participants

Primary outcome timeframe

The MTD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)

Results posted on

2020-04-10

Participant Flow

A total of 69 patients were enrolled at 3 investigational sites: 55 Group A (paclitaxel plus PM01183) and 14 Group B (paclitaxel+PM01183 and BEV). Patients participated in this trial between 15/Oct/2013 and 14/Jul/2016 (last FU). The first dose of the first cycle was given on 23/Oct/2013 and the last dose of the last cycle was given on 23/Jun/2016

Signed IC,Age 18-75,ECOG PS≤1,Life expectancy≥3 months,Histologically/cytologically confirmed diagnosis of advanced and/or unresectable disease according to the groups,adequate status patient,no AEs,negative pregnancy test.

Participant milestones

Participant milestones
Measure	Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD] Cohort I * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 3.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Cohort I: Dose Level 1 STARTED	3	0	0	0	0	0
Cohort I: Dose Level 1 COMPLETED	0	0	0	0	0	0
Cohort I: Dose Level 1 NOT COMPLETED	3	0	0	0	0	0
Cohort II: Dose Level 2 STARTED	0	3	0	0	0	0
Cohort II: Dose Level 2 COMPLETED	0	0	0	0	0	0
Cohort II: Dose Level 2 NOT COMPLETED	0	3	0	0	0	0
Cohort III: Dose Level 3 STARTED	0	0	6	0	0	0
Cohort III: Dose Level 3 COMPLETED	0	0	0	0	0	0
Cohort III: Dose Level 3 NOT COMPLETED	0	0	6	0	0	0
Cohort IV: Dose Level 4 STARTED	0	0	0	6	0	0
Cohort IV: Dose Level 4 COMPLETED	0	0	0	0	0	0
Cohort IV: Dose Level 4 NOT COMPLETED	0	0	0	6	0	0
Cohort V: Dose Level 5 STARTED	0	0	0	0	37	0
Cohort V: Dose Level 5 COMPLETED	0	0	0	0	0	0
Cohort V: Dose Level 5 NOT COMPLETED	0	0	0	0	37	0
Cohort B: Arm B STARTED	0	0	0	0	0	14
Cohort B: Arm B COMPLETED	0	0	0	0	0	0
Cohort B: Arm B NOT COMPLETED	0	0	0	0	0	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD] Cohort I * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 3.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Cohort I: Dose Level 1 Progressive disease	3	0	0	0	0	0
Cohort II: Dose Level 2 Progressive disease	0	2	0	0	0	0
Cohort II: Dose Level 2 Clinical progressive disease	0	1	0	0	0	0
Cohort III: Dose Level 3 Progressive disease	0	0	3	0	0	0
Cohort III: Dose Level 3 Withdrawal by Subject	0	0	1	0	0	0
Cohort III: Dose Level 3 Adverse Event	0	0	1	0	0	0
Cohort III: Dose Level 3 Global end of study	0	0	1	0	0	0
Cohort IV: Dose Level 4 Progressive disease	0	0	0	6	0	0
Cohort V: Dose Level 5 Progressive disease	0	0	0	0	30	0
Cohort V: Dose Level 5 Withdrawal by Subject	0	0	0	0	3	0
Cohort V: Dose Level 5 Death	0	0	0	0	1	0
Cohort V: Dose Level 5 Global end of study	0	0	0	0	2	0
Cohort V: Dose Level 5 Lost to Follow-up	0	0	0	0	1	0
Cohort B: Arm B Progressive disease	0	0	0	0	0	8
Cohort B: Arm B Physician Decision	0	0	0	0	0	2
Cohort B: Arm B Never treated	0	0	0	0	0	2
Cohort B: Arm B Adverse Event	0	0	0	0	0	1
Cohort B: Arm B Global end of study	0	0	0	0	0	1

Baseline Characteristics

Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD] n=3 Participants Cohort I * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 3.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] n=3 Participants Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD n=6 Participants Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] n=6 Participants Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] n=37 Participants Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg n=14 Participants All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	23 Participants n=21 Participants	12 Participants n=8 Participants	51 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	14 Participants n=21 Participants	2 Participants n=8 Participants	18 Participants n=8 Participants
Age, Continuous	57 years n=5 Participants	50 years n=7 Participants	53.5 years n=5 Participants	46.5 years n=4 Participants	61.0 years n=21 Participants	57 years n=8 Participants	57 years n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	26 Participants n=21 Participants	8 Participants n=8 Participants	48 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants	6 Participants n=8 Participants	21 Participants n=8 Participants
Region of Enrollment Switzerland	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	1 Participants n=8 Participants	12 Participants n=8 Participants
Region of Enrollment Spain	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants	6 Participants n=8 Participants	28 Participants n=8 Participants
Region of Enrollment United States	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	19 Participants n=21 Participants	7 Participants n=8 Participants	29 Participants n=8 Participants

PRIMARY outcome

Timeframe: The MTD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)

Population: Three patients at the RD were not evaluable because they did not receive a complete Cycle 1 due to disease-related grade 3 vomiting and early PD, disease-related grade 3 confusional state, and because not enough information for DLT evaluation was collected during Cycle 1.

Outcome measures

Outcome measures
Measure	Group A (Paclitaxel/PM01183) n=52 Participants All participants who received at least 1 dose of Paclitaxel/PM01183, either at 60/3.0, 60/4.0, 60/5.0, 80/5.0, 80/4.0 mg/m2 / mg FD.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Maximum Tolerated Dose (MTD)	NA mg/m2 / mg FD Paclitaxel \[80.0 mg/m2\] / PM01183 \[5.0 mg FD\]	—	—	—	—	—

PRIMARY outcome

Timeframe: The RD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)

The RD will be the highest DL explored with less than one third of the patients experiencing a DLT during Cycle 1. DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1.

Outcome measures

Outcome measures
Measure	Group A (Paclitaxel/PM01183) n=52 Participants All participants who received at least 1 dose of Paclitaxel/PM01183, either at 60/3.0, 60/4.0, 60/5.0, 80/5.0, 80/4.0 mg/m2 / mg FD.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Recommended Dose (RD)	NA mg/m2 / mg FD Paclitaxel \[80.0 mg/m2\] / PM01183 \[4.0 mg FD\]	—	—	—	—	—

PRIMARY outcome

Timeframe: DLT was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)

DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1.

Outcome measures

Outcome measures
Measure	Group A (Paclitaxel/PM01183) n=3 Participants All participants who received at least 1 dose of Paclitaxel/PM01183, either at 60/3.0, 60/4.0, 60/5.0, 80/5.0, 80/4.0 mg/m2 / mg FD.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] n=3 Participants Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD n=6 Participants Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] n=6 Participants Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] n=34 Participants Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg n=12 Participants All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants	2 Participants	3 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)

Best overall response:Best response recorded from the start of the study treatment until the end of treatment Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to\<10 mm Partial Response (PR):At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression) Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on study Treatment failure (TF):symptomatic deterioration or death due to progression

Outcome measures

Outcome measures
Measure	Group A (Paclitaxel/PM01183) n=3 Participants All participants who received at least 1 dose of Paclitaxel/PM01183, either at 60/3.0, 60/4.0, 60/5.0, 80/5.0, 80/4.0 mg/m2 / mg FD.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] n=3 Participants Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD n=6 Participants Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] n=6 Participants Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] n=33 Participants Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg n=10 Participants All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Best Tumor Response CR	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Best Tumor Response PR	1 Participants	0 Participants	2 Participants	4 Participants	12 Participants	4 Participants
Best Tumor Response SD ≥3 months	1 Participants	2 Participants	1 Participants	1 Participants	6 Participants	4 Participants
Best Tumor Response SD <3 months	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Best Tumor Response PD	1 Participants	1 Participants	2 Participants	1 Participants	12 Participants	0 Participants
Best Tumor Response Early PD	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Best Tumor Response TF	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)

Progression-free survival (PFS) was defined as the time from the date of first infusion of study treatment to the date of progression or death (due to any cause). If progression or death had not occurred at the time of the analysis, the PFS was censored.

Outcome measures

Outcome measures
Measure	Group A (Paclitaxel/PM01183) n=3 Participants All participants who received at least 1 dose of Paclitaxel/PM01183, either at 60/3.0, 60/4.0, 60/5.0, 80/5.0, 80/4.0 mg/m2 / mg FD.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] n=3 Participants Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD n=6 Participants Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] n=6 Participants Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] n=33 Participants Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg n=10 Participants All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Progression-free Survival	3.5 months Interval 1.7 to 5.6	3.1 months Interval 1.9 to 7.4	3.1 months Interval 1.0 to Not reached	5.4 months Interval 1.7 to 8.8	3.9 months Interval 1.9 to 6.0	6.7 months Interval 2.4 to 9.3

SECONDARY outcome

Timeframe: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)

Population: In cohort II, no patients with PR or CR.

Duration of response (DR) was defined as the time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented

Outcome measures

Outcome measures
Measure	Group A (Paclitaxel/PM01183) n=1 Participants All participants who received at least 1 dose of Paclitaxel/PM01183, either at 60/3.0, 60/4.0, 60/5.0, 80/5.0, 80/4.0 mg/m2 / mg FD.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD n=2 Participants Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] n=4 Participants Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] n=13 Participants Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg n=5 Participants All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Duration of Response (DR)	1.6 months Not reached	—	NA months Interval 2.0 to Not reached	2.2 months Interval 0.9 to 4.7	4.1 months Interval 2.1 to 8.3	4.6 months Interval 1.4 to Not reached

SECONDARY outcome

Timeframe: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)

Change from baseline to last cycle. European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL scale scores. The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC QLQ-C30 (version 3.0) developed for palliative care. Wilcoxon signed ranks test repeat-measure analyses of variance were used to measure the change value from baseline value. Data has to be analysed following the corresponding EORTC manual http://www.eortc.be/qol/files/SCManualQLQ-C15-PAL.pdf and the overall quality of life assessment is contained in 0 to 100 where a higher value represents a better state.

Outcome measures

Outcome measures
Measure	Group A (Paclitaxel/PM01183) n=3 Participants All participants who received at least 1 dose of Paclitaxel/PM01183, either at 60/3.0, 60/4.0, 60/5.0, 80/5.0, 80/4.0 mg/m2 / mg FD.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] n=3 Participants Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD n=6 Participants Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] n=6 Participants Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] n=26 Participants Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg n=8 Participants All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Quality of Life (QoL) Pain	5.6 score on a scale Standard Deviation 9.6	8.3 score on a scale Standard Deviation 11.8	-13.3 score on a scale Standard Deviation 21.7	13.3 score on a scale Standard Deviation 13.9	-4.2 score on a scale Standard Deviation 21.0	12.5 score on a scale Standard Deviation 30.5
Quality of Life (QoL) Dyspnea	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 47.1	-6.7 score on a scale Standard Deviation 27.9	6.7 score on a scale Standard Deviation 14.9	11.1 score on a scale Standard Deviation 25.4	12.5 score on a scale Standard Deviation 24.8
Quality of Life (QoL) Insomnia	0.0 score on a scale Standard Deviation 33.3	16.7 score on a scale Standard Deviation 23.6	0.0 score on a scale Standard Deviation 0.0	-6.7 score on a scale Standard Deviation 14.9	4.2 score on a scale Standard Deviation 34.5	-12.5 score on a scale Standard Deviation 30.5
Quality of Life (QoL) Appetite loss	-22.2 score on a scale Standard Deviation 38.5	0.0 score on a scale Standard Deviation 0.0	-6.7 score on a scale Standard Deviation 14.9	0.0 score on a scale Standard Deviation 0.0	1.4 score on a scale Standard Deviation 30.3	16.7 score on a scale Standard Deviation 25.2
Quality of Life (QoL) Constipation	11.1 score on a scale Standard Deviation 19.2	0.0 score on a scale Standard Deviation 0.0	6.7 score on a scale Standard Deviation 14.9	13.3 score on a scale Standard Deviation 29.8	-2.8 score on a scale Standard Deviation 23.9	8.3 score on a scale Standard Deviation 23.6
Quality of Life (QoL) Overall QoL	5.6 score on a scale Standard Deviation 9.6	-16.7 score on a scale Standard Deviation 0.0	-8.3 score on a scale Standard Deviation 21.5	-6.7 score on a scale Standard Deviation 19.0	-6.3 score on a scale Standard Deviation 22.4	-10.4 score on a scale Standard Deviation 17.7
Quality of Life (QoL) Physical functioning	-11.1 score on a scale Standard Deviation 19.2	-6.7 score on a scale Standard Deviation 9.4	-2.7 score on a scale Standard Deviation 6.0	-13.3 score on a scale Standard Deviation 8.2	-2.8 score on a scale Standard Deviation 19.8	-8.3 score on a scale Standard Deviation 17.0
Quality of Life (QoL) Fatigue	3.7 score on a scale Standard Deviation 33.9	0.0 score on a scale Standard Deviation 0.0	-2.2 score on a scale Standard Deviation 24.1	11.1 score on a scale Standard Deviation 13.6	6.5 score on a scale Standard Deviation 23.4	2.8 score on a scale Standard Deviation 22.0
Quality of Life (QoL) Nausea / vomiting	-5.6 score on a scale Standard Deviation 9.6	8.3 score on a scale Standard Deviation 11.8	0.0 score on a scale Standard Deviation 11.8	3.3 score on a scale Standard Deviation 7.5	3.5 score on a scale Standard Deviation 9.8	2.4 score on a scale Standard Deviation 6.3
Quality of Life (QoL) Emotional functioning	16.7 score on a scale Standard Deviation 28.9	-8.3 score on a scale Standard Deviation 35.4	0.0 score on a scale Standard Deviation 11.8	5.0 score on a scale Standard Deviation 33.1	6.3 score on a scale Standard Deviation 18.4	5.2 score on a scale Standard Deviation 16.0

Adverse Events

Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD]

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD]

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD]

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD]

Serious events: 15 serious events

Other events: 36 other events

Deaths: 3 deaths

Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg

Serious events: 7 serious events

Other events: 12 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD] n=3 participants at risk Cohort I * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 3.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] n=3 participants at risk Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD n=6 participants at risk Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] n=6 participants at risk Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] n=37 participants at risk Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg n=14 participants at risk All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Vascular disorders Venous thrombosis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor associated fever	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Pyrexia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Chest pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Psychiatric disorders Confusional state	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Investigations Neutrophil count decreased	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Dizziness	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Eye disorders Retinal detachment	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Nausea	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Large intestine perforation	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Hepatobiliary disorders Gallbladder obstruction	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Catheter site cellulitis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Pneumonia pneumococcal	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Sepsis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Abdominal abscess	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.

Other adverse events

Other adverse events
Measure	Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD] n=3 participants at risk Cohort I * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 3.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] n=3 participants at risk Cohort II * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD n=6 participants at risk Cohort III * Paclitaxel 60.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] n=6 participants at risk Cohort IV * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 5.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] n=37 participants at risk Cohort V * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour via a central or peripheral venous catheter through a pump device with an appropriate infusion line and filter. * PM01183 4.0 mg FD as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour via a central catheter (or over a minimum dilution of 250 mL if a peripheral venous catheter was used) through a pump device. Patients in this group were to receive paclitaxel and PM01183 for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, PM01183 could be continued alone until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg n=14 participants at risk All three study medications were administered via a central or a peripheral venous catheter through a pump device, as follows: * Paclitaxel 80.0 mg/m2 as an i.v. infusion on Days 1, 8 and 15 q3wk, over one hour. * PM01183 as an i.v. infusion on Day 1 q3wk, after paclitaxel infusion, over one hour. * Bevacizumab (BEV) 15 mg/kg as an i.v. infusion on Day 1 q3wk, immediately after paclitaxel and PM01183 infusions, Minimum duration of infusion was 90 minutes for the first dose and, if well tolerated, 60 minutes for the second dose and 30 minutes for all subsequent doses. nous catheter was used) through a pump device. Patients in this group were to receive paclitaxel, PM01183 and BEV for up to six cycles, in the absence of disease progression or unacceptable toxicity; then, both PM01183 and BEV could be continued until progression, unacceptable toxicity, patient's decision, or Investigator's decision upon the Sponsors' agreement.
Vascular disorders Thrombosis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Eye disorders Photophobia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Injection site erythema	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Psychiatric disorders Anxiety	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	8.1% 3/37 • Number of events 19 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Vascular disorders Hypertension	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 8 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	21.4% 3/14 • Number of events 13 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	13.5% 5/37 • Number of events 14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Immune system disorders Hypersensitivity	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Chest pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Extravasation	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Fatigue	66.7% 2/3 • Number of events 11 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	100.0% 3/3 • Number of events 23 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	100.0% 6/6 • Number of events 42 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	100.0% 6/6 • Number of events 40 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	73.0% 27/37 • Number of events 153 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	71.4% 10/14 • Number of events 110 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Influenza like illness	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	8.1% 3/37 • Number of events 7 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Oedema peripheral	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	50.0% 3/6 • Number of events 18 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	10.8% 4/37 • Number of events 22 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	10.8% 4/37 • Number of events 16 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 19 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Pyrexia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	66.7% 2/3 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	18.9% 7/37 • Number of events 17 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Psychiatric disorders Depression	33.3% 1/3 • Number of events 7 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	8.1% 3/37 • Number of events 8 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 20 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Psychiatric disorders Insomnia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	13.5% 5/37 • Number of events 34 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 13 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 7 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	8.1% 3/37 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Investigations Neutrophil count decreased	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.2% 6/37 • Number of events 13 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Investigations Weight decreased	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	8.1% 3/37 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	66.7% 4/6 • Number of events 20 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 8 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	29.7% 11/37 • Number of events 40 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	21.4% 3/14 • Number of events 13 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Investigations Weight increased	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 8 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 12 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	8.1% 3/37 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 7 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	21.6% 8/37 • Number of events 45 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	21.4% 3/14 • Number of events 21 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	21.4% 3/14 • Number of events 7 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 11 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	50.0% 3/6 • Number of events 9 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	18.9% 7/37 • Number of events 16 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	21.4% 3/14 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 9 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	66.7% 4/6 • Number of events 17 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	83.3% 5/6 • Number of events 30 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	27.0% 10/37 • Number of events 22 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	21.4% 3/14 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Dizziness	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	10.8% 4/37 • Number of events 19 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Headache	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	8.1% 3/37 • Number of events 26 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 12 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Paraesthesia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	10.8% 4/37 • Number of events 22 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 10 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	32.4% 12/37 • Number of events 59 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 16 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Eye disorders Dry eye	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 23 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Eye disorders Vision blurred	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 9 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 28 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	50.0% 3/6 • Number of events 13 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Ascites	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Constipation	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 9 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	29.7% 11/37 • Number of events 33 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	42.9% 6/14 • Number of events 19 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	66.7% 2/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	35.1% 13/37 • Number of events 29 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	35.7% 5/14 • Number of events 13 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	10.8% 4/37 • Number of events 13 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 16 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	10.8% 4/37 • Number of events 7 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 8 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	66.7% 2/3 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 9 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	66.7% 4/6 • Number of events 16 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	64.9% 24/37 • Number of events 57 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	42.9% 6/14 • Number of events 29 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 10 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	50.0% 3/6 • Number of events 14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	51.4% 19/37 • Number of events 29 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	21.4% 3/14 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Colonic fistula	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Gastrointestinal fistula	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Inguinal hernia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Renal and urinary disorders Renal failure acute	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	83.3% 5/6 • Number of events 36 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	24.3% 9/37 • Number of events 47 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	35.7% 5/14 • Number of events 24 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 11 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 18 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 7 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 7 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 38 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	21.4% 3/14 • Number of events 17 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 12 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Hypertrophic osteoarthropathy	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	27.0% 10/37 • Number of events 38 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	28.6% 4/14 • Number of events 20 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Thrombosis in device	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 18 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	8.1% 3/37 • Number of events 7 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Infusion site phlebitis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 2/6 • Number of events 23 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Respiratory tract infection	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	14.3% 2/14 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Abdominal abscess	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Abdominal infection	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Infection	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Nasopharyngitis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Septic shock	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Tooth abscess	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	7.1% 1/14 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Subileus	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Enteritis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Mucosal inflammation	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Oedema	33.3% 1/3 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Catheter site inflammation	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Chills	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Face oedema	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 5 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Infusion site thrombosis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
General disorders Malaise	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Urinary tract infection	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Lung infection	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Pneumonia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Enterococcal infection	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Herpes zoster	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Influenza	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Nail infection	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Pharyngitis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Oral herpes	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Cellulitis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Oral candidiasis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Investigations Blood cholesterol increased	33.3% 1/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Metabolism and nutrition disorders Hypertriglyceridaemia	33.3% 1/3 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Disturbance in attention	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Memory impairment	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Presyncope	33.3% 1/3 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Somnolence	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	2.7% 1/37 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Agitation	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Psychiatric disorders Libido decreased	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 8 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Dermatitis acneiform	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Vascular disorders Jugular vein thrombosis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	33.3% 1/3 • Number of events 4 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Cardiac disorders Palpitations	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	5.4% 2/37 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Renal and urinary disorders Urinary tract pain	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.
Nervous system disorders Dysaesthesia	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/3 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/6 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/37 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.	0.00% 0/14 • Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks) In Group B: 14 patients were included, although only 12 were treated.

Additional Information

Clinical Development Department of PharmaMar´s Oncology Business Unit.

Pharma Mar, S.A.

Phone: +34 91 846 60 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60