Trial Outcomes & Findings for Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation (NCT NCT01574716)

NCT ID: NCT01574716

Last Updated: 2019-08-21

Results Overview

PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 209 participants
• Primary outcome timeframe: From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)
• Results posted on: 2019-08-21

Participant Flow

Participants took part in the study at 31 investigative sites in the United States, Australia, Italy, Netherlands, France and Belgium from 07 August 2012 to 02 August 2016.

In Part 1, a total of 16 participants were enrolled and treated in the study. A total of 225 participants were screened for entry into Part 2 of the study. Of these 225 participants, 46 were screen failures and 209 were randomized into the study, of which 207 participants were treated.

Participant milestones

Measure	Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel Participants received MORAb-004 4 milligram per kilogram (mg/kg), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 milligram per square meter (mg/m\^2), infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel Participants received normal saline (0.9 percent \[%\] sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Part 1 STARTED	3	4	9	0	0
Part 1 COMPLETED	0	0	0	0	0
Part 1 NOT COMPLETED	3	4	9	0	0
Part 2 STARTED	0	0	0	139	70
Part 2 Treated Participants	0	0	0	140	67
Part 2 COMPLETED	0	0	0	2	0
Part 2 NOT COMPLETED	0	0	0	137	70

Reasons for withdrawal

Measure	Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel Participants received MORAb-004 4 milligram per kilogram (mg/kg), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 milligram per square meter (mg/m\^2), infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel Participants received normal saline (0.9 percent \[%\] sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Part 1 Death	3	1	8	0	0
Part 1 Discontinuation of study by sponsor	0	0	1	0	0
Part 1 Withdrawal by Subject	0	2	0	0	0
Part 1 Lost to Follow-up	0	1	0	0	0
Part 2 Progressive disease	0	0	0	1	0
Part 2 Death	0	0	0	76	35
Part 2 Discontinuation of study by sponsor	0	0	0	51	31
Part 2 Withdrawal by Subject	0	0	0	5	4
Part 2 Brain metastases	0	0	0	1	0
Part 2 Lost to Follow-up	0	0	0	3	0

Baseline Characteristics

Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation

Baseline characteristics by cohort

Measure	Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel n=3 Participants Participants received MORAb-004 4 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel n=4 Participants Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=9 Participants Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=139 Participants Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel n=70 Participants Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Total n=225 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
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	103 Participants n=4 Participants	49 Participants n=21 Participants	166 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	36 Participants n=4 Participants	21 Participants n=21 Participants	59 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	63 Participants n=4 Participants	32 Participants n=21 Participants	102 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	76 Participants n=4 Participants	38 Participants n=21 Participants	123 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	18 Participants n=4 Participants	8 Participants n=21 Participants	29 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	119 Participants n=4 Participants	61 Participants n=21 Participants	193 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	116 Participants n=4 Participants	57 Participants n=21 Participants	185 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	12 Participants n=4 Participants	9 Participants n=21 Participants	23 Participants n=8 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	2 Participants n=21 Participants	11 Participants n=8 Participants
Race/Ethnicity, Customized Chinese	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants

PRIMARY outcome

Timeframe: From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)

Population: The ITT population consisted of all randomized participants and were analyzed according to the treatment assigned by the IxRS.

PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.

Outcome measures

Measure	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=139 Participants Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel n=70 Participants Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Part 2: Radiologic Progression-free Survival (PFS)	18.7 weeks Interval 11.6 to 27.4	24.1 weeks Interval 11.1 to 36.1

SECONDARY outcome

Timeframe: From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)

Population: The ITT population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.

PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause.

Outcome measures

Measure	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=139 Participants Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel n=70 Participants Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Part 2: Symptomatic Progression-free Survival	18.1 weeks Interval 11.3 to 24.0	24.0 weeks Interval 10.7 to 36.1

SECONDARY outcome

Timeframe: From date of first dose until date of death from any cause (up to approximately 3.5 years)

Population: The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.

OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.

Outcome measures

Measure	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=139 Participants Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel n=70 Participants Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Part 2: Overall Survival (OS)	18.3 months Interval 16.2 to 21.1	21.1 months Interval 14.2 to The upper limit of confidence interval (CI), was not estimable since high number of participants were censored from analysis.

SECONDARY outcome

Timeframe: From date of first dose until disease progression (up to approximately 3.5 years)

Population: The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.

ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=139 Participants Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel n=70 Participants Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Part 2: Overall Response Rate (ORR)	19.4 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 12, 24, 48 and 52

Population: The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.

Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.

Outcome measures

Measure	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=139 Participants Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel n=70 Participants Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Part 2: Radiologic Progression-free Survival Rate (PFR) 12 weeks	57.6 percentage of participants	61.8 percentage of participants
Part 2: Radiologic Progression-free Survival Rate (PFR) 24 weeks	43.3 percentage of participants	51.0 percentage of participants
Part 2: Radiologic Progression-free Survival Rate (PFR) 48 weeks	24.5 percentage of participants	25.2 percentage of participants
Part 2: Radiologic Progression-free Survival Rate (PFR) 52 weeks	20.8 percentage of participants	21.4 percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.

Outcome measures

Measure	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=139 Participants Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel n=70 Participants Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels	0 participants	0 participants

Adverse Events

Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel

Serious events: 6 serious events

Other events: 9 other events

Deaths: 8 deaths

Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel

Serious events: 106 serious events

Other events: 140 other events

Deaths: 76 deaths

Part 2: Placebo + Gemcitabine/Docetaxel

Serious events: 45 serious events

Other events: 66 other events

Deaths: 35 deaths

Serious adverse events

Measure	Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel n=3 participants at risk Participants received MORAb-004 4 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel n=4 participants at risk Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=9 participants at risk Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=140 participants at risk Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel n=67 participants at risk Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Vascular disorders Capillary leak syndrome	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.6% 5/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	2.1% 3/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	33.3% 3/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.5% 3/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Cardiac disorders Atrial flutter	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Cardiac disorders Atrial thrombosis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Cardiac disorders Cardiac arrest	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Cardiac disorders Cardiac failure	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Cardiac disorders Diastolic dysfunction	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Cardiac disorders Pericardial effusion	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Abdominal hernia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Colitis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Constipation	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Ileus	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Intussusception	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Nausea	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	2.9% 4/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Oesophagitis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Pancreatic cyst	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Vomiting	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	2.1% 3/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Chills	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Generalised oedema	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Infusion site extravasation	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Mucosal inflammation	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Non-cardiac chest pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Oedema peripheral	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Pyrexia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Systemic inflammatory response syndrome	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Hepatobiliary disorders Hepatotoxicity	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Immune system disorders Cytokine release syndrome	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Immune system disorders Hypersensitivity	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Campylobacter gastroenteritis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Cellulitis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.5% 3/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Corona virus infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Enterocolitis infectious	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Escherichia sepsis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Influenza	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Liver abscess	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Lobar pneumonia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Lung infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	2.1% 3/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Neutropenic sepsis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Pneumocystis jiroveci infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Pneumocystis jiroveci pneumonia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Pneumonia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	9.0% 6/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Pneumonia primary atypical	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Respiratory tract infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Sepsis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Soft tissue infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Urinary tract infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	2.1% 3/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Wound infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Injury, poisoning and procedural complications Femur fracture	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Injury, poisoning and procedural complications Rib fracture	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Blood creatinine increased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Neutrophil count decreased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Platelet count decreased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.5% 3/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations White blood cell count decreased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.3% 6/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.5% 3/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Depressed level of consciousness	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Embolic stroke	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Encephalopathy	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Lethargy	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Memory impairment	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Presyncope	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Syncope	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Transient global amnesia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Psychiatric disorders Confusional state	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Psychiatric disorders Mental status changes	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Renal and urinary disorders Haematuria	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Renal and urinary disorders Renal failure	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Renal and urinary disorders Renal failure acute	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.3% 6/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.5% 3/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	2.1% 3/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Pleural haemorrhage	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	2.9% 4/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	2.1% 3/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Vascular disorders Deep vein thrombosis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.4% 2/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Vascular disorders Hypertension	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Vascular disorders Hypotension	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Vascular disorders Vena cava thrombosis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.71% 1/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)

Other adverse events

Measure	Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel n=3 participants at risk Participants received MORAb-004 4 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel n=4 participants at risk Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=9 participants at risk Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n=140 participants at risk Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.	Part 2: Placebo + Gemcitabine/Docetaxel n=67 participants at risk Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Gastrointestinal disorders Vomiting	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	50.0% 2/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	27.1% 38/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	16.4% 11/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	12.1% 17/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.5% 5/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	88.9% 8/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	60.7% 85/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	55.2% 37/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Thrombocytopenia	100.0% 3/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	88.9% 8/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	40.0% 56/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	41.8% 28/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	50.0% 2/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	44.4% 4/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.9% 32/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.4% 15/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Blood and lymphatic system disorders Leukopenia	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	14.3% 20/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	16.4% 11/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Eye disorders Lacrimation Increased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	9.0% 6/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Nausea	66.7% 2/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	55.6% 5/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	53.6% 75/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	50.7% 34/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Constipation	66.7% 2/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	38.6% 54/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	37.3% 25/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	50.0% 2/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.9% 11/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.4% 15/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	43.6% 61/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	35.8% 24/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.1% 10/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.4% 9/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	9.0% 6/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Dry Mouth	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.5% 5/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Gastrooesophageal Reflux Disease	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Fatigue	100.0% 3/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	75.0% 3/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	66.7% 6/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	73.6% 103/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	65.7% 44/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Oedema peripheral	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	50.0% 2/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	42.1% 59/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	43.3% 29/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Pyrexia	66.7% 2/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	44.4% 4/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	36.4% 51/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.4% 17/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Chills	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	20.0% 28/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.5% 3/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Influenza Like Illness	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	10.7% 15/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Mucosal Inflammation	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	8.6% 12/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	9.0% 6/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.9% 11/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Asthenia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Chest Pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Non-Cardiac Chest Pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	12.1% 17/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.5% 3/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Urinary Tract Infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	9.3% 13/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Cellulitis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.4% 9/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Nasopharyngitis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.5% 3/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Pneumonia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Sinusitis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Injury, poisoning and procedural complications Infusion Related Reaction	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.1% 10/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Alanine Aminotransferase Increased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	33.3% 3/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.1% 31/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	17.9% 12/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Platelet Count Decreased	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	14.3% 20/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.4% 15/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Aspartate Aminotransferase Increased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.4% 16/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.9% 8/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Blood Alkaline Phosphatase Increased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	9.3% 13/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	10.4% 7/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Neutrophil Count Decreased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	9.3% 13/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	13.4% 9/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations White Blood Cell Count Decreased	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.9% 11/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	14.9% 10/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Blood Creatinine Increased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.1% 10/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Blood Albumin Decreased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Lymphocyte Count Decreased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.9% 8/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Weight Decreased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Investigations Blood Calcium Decreased	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	30.7% 43/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	23.9% 16/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	33.3% 3/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	13.6% 19/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	10.4% 7/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	15.7% 22/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	8.6% 12/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.1% 10/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.5% 5/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	75.0% 3/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	15.0% 21/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	19.4% 13/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	50.0% 2/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	17.9% 25/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	19.4% 13/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	75.0% 3/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	15.0% 21/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.4% 15/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	24.3% 34/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	19.4% 13/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	14.3% 20/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	14.9% 10/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	10.0% 14/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.5% 5/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Headache	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	50.0% 2/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	33.3% 3/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	40.7% 57/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	19.4% 13/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Dysgeusia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.1% 31/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.4% 15/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Dizziness	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.4% 16/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	14.9% 10/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Neuropathy Peripheral	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.4% 16/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	23.9% 16/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Paraesthesia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	10.0% 14/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	10.4% 7/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Peripheral Sensory Neuropathy	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.7% 8/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.5% 5/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Psychiatric disorders Insomnia	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	17.1% 24/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	17.9% 12/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Psychiatric disorders Anxiety	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Psychiatric disorders Depression	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	30.0% 42/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	34.3% 23/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	29.3% 41/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	26.9% 18/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	12.9% 18/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	14.9% 10/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	8.6% 12/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	10.4% 7/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.9% 11/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.5% 5/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.1% 10/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.5% 3/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Alopecia	66.7% 2/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	34.3% 48/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	31.3% 21/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	21.4% 30/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	34.3% 23/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	14.3% 20/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	4.5% 3/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	8.6% 12/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	1.5% 1/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.1% 10/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.5% 5/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	7.1% 10/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Vascular disorders Hypertension	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	12.1% 17/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	3.0% 2/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Vascular disorders Hot Flush	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.4% 9/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Vascular disorders Flushing	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	6.0% 4/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Vascular disorders Hypotension	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	5.0% 7/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	10.4% 7/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Ear and labyrinth disorders Deafness Unilateral	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Ear and labyrinth disorders Ear Pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Eye disorders Conjunctivitis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Eye disorders Dry Eye	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Eye disorders Vision Blurred	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Dental Caries	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Flatulence	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Frequent Bowel Movements	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Gastrointestinal disorders Peptic Ulcer	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Catheter Site Rash	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
General disorders Early Satiety	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Diverticulitis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Gastrointestinal Viral Infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Lower Respiratory Tract Infection Viral	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Oral Candidiasis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Staphylococcal Skin Infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	50.0% 2/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Injury, poisoning and procedural complications Tooth Fracture	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Metabolism and nutrition disorders Increased Appetite	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Groin Pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Muscle Twitching	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Musculoskeletal and connective tissue disorders Pain In Jaw	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Pain	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Hyperaesthesia	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Loss Of Consciousness	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Nervous system disorders Neuralgia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Renal and urinary disorders Dysuria	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Renal and urinary disorders Urinary Tract Obstruction	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	22.2% 2/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Hiccups	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Oropharyngeal Discomfort	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 1/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Nail Disorder	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	11.1% 1/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Skin and subcutaneous tissue disorders Skin Exfoliation	0.00% 0/3 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	25.0% 1/4 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/9 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/140 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)	0.00% 0/67 • From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: 1-888-274-2378

Email: esi_oncmedinfo@eisai.com

Results disclosure agreements

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

Restriction type: OTHER