Trial Outcomes & Findings for Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC (NCT NCT01761240)

NCT ID: NCT01761240

Last Updated: 2024-03-29

Results Overview

Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 27 participants
• Primary outcome timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
• Results posted on: 2024-03-29

Participant Flow

Participants took part in the study at 2 investigative sites in the United States from 19 June 2013 to 09 February 2016.

A total of 27 participants were enrolled and treated in the study.

Participant milestones

Measure	MORAb-066 0.1 mg/kg Participants received MORAb-066 0.1 milligram per kilogram (mg/kg), infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Overall Study STARTED	3	4	5	7	8
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	3	4	5	7	8

Reasons for withdrawal

Measure	MORAb-066 0.1 mg/kg Participants received MORAb-066 0.1 milligram per kilogram (mg/kg), infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Overall Study Progressive disease:radiology assessment	3	3	0	0	0
Overall Study Progressive disease:clinical assessment	0	0	3	1	0
Overall Study Withdrawal by Subject	0	0	0	3	1
Overall Study Adverse Event	0	0	0	1	6
Overall Study Death	0	1	1	2	1
Overall Study Non-compliance	0	0	1	0	0

Baseline Characteristics

Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC

Baseline characteristics by cohort

Measure	MORAb-066 0.1 mg/kg n=3 Participants Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=4 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=5 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=7 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=8 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	Total n=27 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 7.21 • n=5 Participants	57.8 years STANDARD_DEVIATION 9.39 • n=7 Participants	55.2 years STANDARD_DEVIATION 6.06 • n=5 Participants	62.4 years STANDARD_DEVIATION 7.98 • n=4 Participants	64.3 years STANDARD_DEVIATION 8.75 • n=21 Participants	60.8 years STANDARD_DEVIATION 8.18 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	15 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	12 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	24 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	8 Participants n=21 Participants	22 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	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

PRIMARY outcome

Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)

Population: The safety analysis set was the group of participants who received at least 1 dose of study drug.

Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations.

Outcome measures

Measure	MORAb-066 0.1 mg/kg n=3 Participants Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=4 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=5 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=7 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=8 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	3 Participants	4 Participants	5 Participants	7 Participants	8 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	1 Participants	3 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Cycle 1 (Cycle length=28 days)

Population: The DLT evaluable set included all participants who were evaluable for the DLTs in first cycle and had taken at least 1 dose of study drug.

DLT was defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade.

Outcome measures

Measure	MORAb-066 0.1 mg/kg n=3 Participants Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=4 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=5 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=7 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=8 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Number of Participants With Dose Limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Cycle 1 (Cycle length=28 days)

Population: The DLT evaluable set included all participants who were evaluable for the DLTs in first cycle and had taken at least 1 dose of study drug.

The MTD was defined as the highest dose level at which no more than one out of six participants experienced DLT. DLT was defined using NCI CTCAE Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade.

Outcome measures

Measure	MORAb-066 0.1 mg/kg n=27 Participants Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Maximum Tolerated Dose (MTD)	2 mg/kg	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)

Population: The pharmacokinetic (PK) analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.

Outcome measures

Measure	MORAb-066 0.1 mg/kg n=3 Participants Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=4 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=5 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=7 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=8 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Cmax: Maximum Observed Serum Concentration for MORAb-066 Cycle 1 Day 1	2.09 microgram per milliliter (mcg/mL) Standard Deviation 0.186	5.26 microgram per milliliter (mcg/mL) Standard Deviation 0.826	23.40 microgram per milliliter (mcg/mL) Standard Deviation 5.697	45.65 microgram per milliliter (mcg/mL) Standard Deviation 12.370	68.61 microgram per milliliter (mcg/mL) Standard Deviation 13.201
Cmax: Maximum Observed Serum Concentration for MORAb-066 Cycle 1 Day 22	1.95 microgram per milliliter (mcg/mL) Standard Deviation 0.731	4.33 microgram per milliliter (mcg/mL) Standard Deviation 0.014	21.33 microgram per milliliter (mcg/mL) Standard Deviation 7.106	52.68 microgram per milliliter (mcg/mL) Standard Deviation 12.544	121.50 microgram per milliliter (mcg/mL) Standard Deviation 30.406

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)

Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.

Outcome measures

Measure	MORAb-066 0.1 mg/kg n=3 Participants Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=4 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=5 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=7 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=8 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Tmax: Time to Reach Maximum Serum Concentration for MORAb-066 Cycle 1 Day 1	1.28 hours Interval 1.27 to 3.07	1.30 hours Interval 1.25 to 3.0	1.25 hours Interval 1.02 to 3.0	1.80 hours Interval 1.7 to 3.07	1.82 hours Interval 1.75 to 3.93
Tmax: Time to Reach Maximum Serum Concentration for MORAb-066 Cycle 1 Day 22	1.33 hours Interval 1.25 to 2.0	1.25 hours Interval 1.25 to 1.25	1.25 hours Interval 1.22 to 43.27	1.92 hours Interval 1.37 to 3.52	1.77 hours Interval 1.75 to 1.78

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)

Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.

Outcome measures

Measure	MORAb-066 0.1 mg/kg Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=2 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=4 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=1 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=1 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
t1/2: Terminal Elimination Phase Half-Life for MORAb-066 Cycle 1 Day 1	—	30.8 hours Standard Deviation 10.68	52.2 hours Standard Deviation 10.22	80.2 hours Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	57.1 hours Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
t1/2: Terminal Elimination Phase Half-Life for MORAb-066 Cycle 1 Day 22	—	24.1 hours Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	44.6 hours Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	—	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)

Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.

Outcome measures

Measure	MORAb-066 0.1 mg/kg n=3 Participants Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=4 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=5 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=6 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=8 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
AUC(0-t): Area Under the Serum Concentration-time Curve From Zero Time to the Last Measurable Point for MORAb-066 Cycle 1 Day 1	95.5 hours*microgram/milliliter Standard Deviation 44.92	202.3 hours*microgram/milliliter Standard Deviation 41.48	1535.6 hours*microgram/milliliter Standard Deviation 589.97	2415.5 hours*microgram/milliliter Standard Deviation 1245.84	4536.3 hours*microgram/milliliter Standard Deviation 1104.35
AUC(0-t): Area Under the Serum Concentration-time Curve From Zero Time to the Last Measurable Point for MORAb-066 Cycle 1 Day 22	61.2 hours*microgram/milliliter Standard Deviation 25.09	188.5 hours*microgram/milliliter Standard Deviation 51.62	1541.3 hours*microgram/milliliter Standard Deviation 1245.66	5188.0 hours*microgram/milliliter Standard Deviation 1911.22	10420.0 hours*microgram/milliliter Standard Deviation 1244.51

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)

Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here,"Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.

Outcome measures

Measure	MORAb-066 0.1 mg/kg Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=2 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=4 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=1 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=1 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
AUC(0-Inf): Area Under the Serum Concentration-time Curve From Zero to Infinity for MORAb-066 Cycle 1 Day 1	—	249 hour*microgram per milliliter Standard Deviation 4.2	1569 hour*microgram per milliliter Standard Deviation 707.9	4210 hour*microgram per milliliter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	5970 hour*microgram per milliliter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
AUC(0-Inf): Area Under the Serum Concentration-time Curve From Zero to Infinity for MORAb-066 Cycle 1 Day 22	—	227 hour*microgram per milliliter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	1410 hour*microgram per milliliter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	—	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)

Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.

Outcome measures

Measure	MORAb-066 0.1 mg/kg Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=2 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=4 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=1 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=1 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Vd: Volume of Distribution for MORAb-066 Cycle 1 Day 1	—	5.06 liter Standard Deviation 3.960	3.89 liter Standard Deviation 1.029	3.88 liter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	4.01 liter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Vd: Volume of Distribution for MORAb-066 Cycle 1 Day 22	—	3.68 liter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	2.55 liter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	—	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)

Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.

Outcome measures

Measure	MORAb-066 0.1 mg/kg Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=2 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=4 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=1 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=1 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
CL: Total Body Clearance for MORAb-066 Cycle 1 Day 1	—	0.1048 liter per hour Standard Deviation 0.05268	0.0516 liter per hour Standard Deviation 0.00894	0.0362 liter per hour Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	0.0488 liter per hour Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
CL: Total Body Clearance for MORAb-066 Cycle 1 Day 22	—	0.1060 liter per hour Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	0.0396 liter per hour Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	—	—

SECONDARY outcome

Timeframe: Up to approximately 2 years 7 months

Population: The efficacy analysis set was the group of participants who received at least 1 dose of study drug.

BOR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target and non-target lesions is complete response (CR) or partial response (PR). CR: disappearance of target and non-target lesions, normalization of tumor marker level, all lymph nodes must be non-pathological in size (less than 10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Outcome measures

Measure	MORAb-066 0.1 mg/kg n=3 Participants Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=4 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=5 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=7 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=8 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Number of Participants With Best Overall Response (BOR) Stable Disease	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Best Overall Response (BOR) Progressive Disease	3 Participants	3 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Best Overall Response (BOR) Not Assessed	0 Participants	1 Participants	3 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to approximately 2 years 7 months

Population: The ADA evaluable population was the participants who received at least one dose of study drug and had at least one post-baseline ADA sample.

Outcome measures

Measure	MORAb-066 0.1 mg/kg n=3 Participants Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=4 Participants Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=4 Participants Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=6 Participants Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=4 Participants Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Number of Participants Positive for Antidrug Antibodies (ADA)	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants

Adverse Events

MORAb-066 0.1 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

MORAb-066 0.3 mg/kg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

MORAb-066 1 mg/kg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 1 deaths

MORAb-066 2 mg/kg

Serious events: 4 serious events

Other events: 7 other events

Deaths: 2 deaths

MORAb-066 3 mg/kg

Serious events: 3 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Measure	MORAb-066 0.1 mg/kg n=3 participants at risk Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=4 participants at risk Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=5 participants at risk Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=7 participants at risk Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=8 participants at risk Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Psychiatric disorders Mental status changes	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Renal and urinary disorders Haematuria	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 2/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Blood and lymphatic system disorders Coagulopathy	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)

Other adverse events

Measure	MORAb-066 0.1 mg/kg n=3 participants at risk Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 0.3 mg/kg n=4 participants at risk Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 1 mg/kg n=5 participants at risk Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 2 mg/kg n=7 participants at risk Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	MORAb-066 3 mg/kg n=8 participants at risk Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
Gastrointestinal disorders Vomiting	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	50.0% 2/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	80.0% 4/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	42.9% 3/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	50.0% 2/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Nausea	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	80.0% 4/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Constipation	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	28.6% 2/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	28.6% 2/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Haematochezia	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	28.6% 2/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Flatulence	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Colitis microscopic	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Duodenitis	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Frequent bowel movements	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Gastritis	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Melaena	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Fatigue	66.7% 2/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	50.0% 2/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	60.0% 3/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	28.6% 2/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 2/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Pyrexia	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	28.6% 2/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 2/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Chills	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	50.0% 2/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Asthenia	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Oedema peripheral	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Pain	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	40.0% 2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Chest discomfort	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Local swelling	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Localised oedema	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Mucosal inflammation	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
General disorders Nodule	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Renal and urinary disorders Haematuria	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	71.4% 5/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	75.0% 6/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Renal and urinary disorders Dysuria	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Renal and urinary disorders Pollakiuria	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Renal and urinary disorders Renal failure acute	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Renal and urinary disorders Renal failure	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Renal and urinary disorders Urinary retention	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	28.6% 2/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	60.0% 3/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	28.6% 2/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	50.0% 2/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	40.0% 2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	37.5% 3/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Blood and lymphatic system disorders Iron deficiency anaemia	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Infections and infestations Urinary tract infection	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	42.9% 3/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 2/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Infections and infestations Oral herpes	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Infections and infestations Pneumonia	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Infections and infestations Rash pustular	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Infections and infestations Respiratory tract infection	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Investigations Blood creatinine increased	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	50.0% 2/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 2/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Investigations International normalised ratio increased	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 2/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Investigations Blood bilirubin increased	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Investigations Aspartate aminotransferase increased	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Investigations Cardiac murmur	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Investigations Prothrombin time prolonged	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Musculoskeletal and connective tissue disorders Flank pain	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Nervous system disorders Headache	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Nervous system disorders Dizziness	66.7% 2/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Nervous system disorders Sciatica	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Psychiatric disorders Confusional state	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Psychiatric disorders Insomnia	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Psychiatric disorders Anxiety	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Psychiatric disorders Delirium	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Skin and subcutaneous tissue disorders Facial wasting	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Skin and subcutaneous tissue disorders Night sweats	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Injury, poisoning and procedural complications Fall	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	25.0% 1/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Immune system disorders Seasonal allergy	33.3% 1/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Reproductive system and breast disorders Penile pain	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Cardiac disorders Tachycardia	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Ear and labyrinth disorders Ear congestion	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Eye disorders Vision blurred	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	20.0% 1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	14.3% 1/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Vascular disorders Hypotension	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/4 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	0.00% 0/7 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)	12.5% 1/8 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)

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