Trial Outcomes & Findings for Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET (NCT NCT02544633)

Last Updated: 2020-03-04

Results Overview

Objective disease response is defined as the percent of patients documented by investigator assessment to have a confirmed Complete Response (CR) or Partial Response (PR) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target and non-target lesions as assessed by CT or MRI. CR is defined as complete disappearance of all target lesions with the exception of nodal disease; PR is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions; Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression; Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

Up to 3 months

Results posted on

2020-03-04

Participant Flow

Sponsor approval of each potential patient's genetic testing following prescreening, whether performed by the study central lab or a Sponsor-approved local lab, was filed prior to proceeding to full clinical screening. All patients considered eligible for the study following clinical screening were submitted to Sponsor for registration approval.

Participant milestones

Participant milestones
Measure	MET Activating Mutations in Tumor Tissue MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	MET Gene Amplifications in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
Treatment Period STARTED	28	20	8	12
Treatment Period COMPLETED	0	0	0	0
Treatment Period NOT COMPLETED	28	20	8	12
Survival Follow-up Period STARTED	28	19	7	12
Survival Follow-up Period COMPLETED	0	0	0	0
Survival Follow-up Period NOT COMPLETED	28	19	7	12

Reasons for withdrawal

Reasons for withdrawal
Measure	MET Activating Mutations in Tumor Tissue MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	MET Gene Amplifications in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
Treatment Period Patient Still on Treatment/Study	0	1	1	0
Treatment Period Adverse Event	7	4	0	5
Treatment Period Lack of Efficacy	17	11	5	5
Treatment Period Global Deterioration of Health	3	3	0	1
Treatment Period Withdrawal by Subject	1	0	0	0
Treatment Period Lost to Follow-up	0	1	0	0
Treatment Period Death	0	0	1	0
Treatment Period Non-compliance	0	0	1	0
Treatment Period Clinical Disease Progression	0	0	0	1
Survival Follow-up Period Death	12	14	3	9
Survival Follow-up Period Lost to Follow-up	0	1	1	0
Survival Follow-up Period Withdrawal by Subject	4	0	1	0
Survival Follow-up Period Study Terminated by Sponsor	12	4	2	3

Baseline Characteristics

Some patients did not have height recorded at baseline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MET Activating Mutations in Tumor Tissue n=28 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=20 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=8 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	MET Gene Amplifications in ctDNA n=12 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	Total n=68 Participants Total of all reporting groups
Age, Customized Mean (STD)	70.7 years STANDARD_DEVIATION 6.02 • n=28 Participants	61.8 years STANDARD_DEVIATION 13.17 • n=20 Participants	59.1 years STANDARD_DEVIATION 7.70 • n=8 Participants	64.8 years STANDARD_DEVIATION 11.09 • n=12 Participants	65.7 years STANDARD_DEVIATION 10.51 • n=68 Participants
Sex: Female, Male Female	16 Participants n=28 Participants	4 Participants n=20 Participants	6 Participants n=8 Participants	6 Participants n=12 Participants	32 Participants n=68 Participants
Sex: Female, Male Male	12 Participants n=28 Participants	16 Participants n=20 Participants	2 Participants n=8 Participants	6 Participants n=12 Participants	36 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=28 Participants	0 Participants n=20 Participants	1 Participants n=8 Participants	0 Participants n=12 Participants	1 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=28 Participants	20 Participants n=20 Participants	7 Participants n=8 Participants	12 Participants n=12 Participants	67 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	0 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Asian	4 Participants n=28 Participants	6 Participants n=20 Participants	2 Participants n=8 Participants	2 Participants n=12 Participants	14 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Black or African American	2 Participants n=28 Participants	1 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	3 Participants n=68 Participants
Race (NIH/OMB) White	21 Participants n=28 Participants	13 Participants n=20 Participants	6 Participants n=8 Participants	10 Participants n=12 Participants	50 Participants n=68 Participants
Race (NIH/OMB) More than one race	0 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	1 Participants n=68 Participants
Race/Ethnicity, Customized White	21 Participants n=28 Participants	13 Participants n=20 Participants	6 Participants n=8 Participants	10 Participants n=12 Participants	50 Participants n=68 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=28 Participants	1 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	3 Participants n=68 Participants
Race/Ethnicity, Customized Asian	4 Participants n=28 Participants	6 Participants n=20 Participants	2 Participants n=8 Participants	2 Participants n=12 Participants	14 Participants n=68 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	0 Participants n=68 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	0 Participants n=68 Participants
Race/Ethnicity, Customized Other	1 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	1 Participants n=68 Participants
Region of Enrollment South Korea	2 Participants n=28 Participants	6 Participants n=20 Participants	0 Participants n=8 Participants	2 Participants n=12 Participants	10 Participants n=68 Participants
Region of Enrollment Hungary	0 Participants n=28 Participants	1 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	1 Participants n=68 Participants
Region of Enrollment United States	23 Participants n=28 Participants	10 Participants n=20 Participants	5 Participants n=8 Participants	7 Participants n=12 Participants	45 Participants n=68 Participants
Region of Enrollment Poland	0 Participants n=28 Participants	0 Participants n=20 Participants	1 Participants n=8 Participants	2 Participants n=12 Participants	3 Participants n=68 Participants
Region of Enrollment Italy	0 Participants n=28 Participants	1 Participants n=20 Participants	0 Participants n=8 Participants	1 Participants n=12 Participants	2 Participants n=68 Participants
Region of Enrollment United Kingdom	1 Participants n=28 Participants	0 Participants n=20 Participants	2 Participants n=8 Participants	0 Participants n=12 Participants	3 Participants n=68 Participants
Region of Enrollment Australia	2 Participants n=28 Participants	2 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	4 Participants n=68 Participants
Height	168.63 cm STANDARD_DEVIATION 9.74 • n=26 Participants • Some patients did not have height recorded at baseline	173.18 cm STANDARD_DEVIATION 8.77 • n=20 Participants • Some patients did not have height recorded at baseline	161.11 cm STANDARD_DEVIATION 8.10 • n=4 Participants • Some patients did not have height recorded at baseline	167.70 cm STANDARD_DEVIATION 8.98 • n=12 Participants • Some patients did not have height recorded at baseline	169.43 cm STANDARD_DEVIATION 9.52 • n=62 Participants • Some patients did not have height recorded at baseline
Body Mass Index	25.16 kg/m^2 STANDARD_DEVIATION 4.58 • n=26 Participants • BMI unable to be calculated in patients with no height recorded at baseline	24.92 kg/m^2 STANDARD_DEVIATION 4.46 • n=20 Participants • BMI unable to be calculated in patients with no height recorded at baseline	22.24 kg/m^2 STANDARD_DEVIATION 2.34 • n=4 Participants • BMI unable to be calculated in patients with no height recorded at baseline	21.80 kg/m^2 STANDARD_DEVIATION 4.18 • n=12 Participants • BMI unable to be calculated in patients with no height recorded at baseline	24.24 kg/m^2 STANDARD_DEVIATION 4.49 • n=62 Participants • BMI unable to be calculated in patients with no height recorded at baseline
Weight	70.85 kg STANDARD_DEVIATION 17.64 • n=28 Participants	75.33 kg STANDARD_DEVIATION 17.77 • n=20 Participants	60.97 kg STANDARD_DEVIATION 8.68 • n=8 Participants	61.58 kg STANDARD_DEVIATION 13.56 • n=12 Participants	69.37 kg STANDARD_DEVIATION 16.85 • n=68 Participants
ECOG Performance Status 0	10 Participants n=28 Participants	6 Participants n=20 Participants	2 Participants n=8 Participants	2 Participants n=12 Participants	20 Participants n=68 Participants
ECOG Performance Status 1	16 Participants n=28 Participants	12 Participants n=20 Participants	6 Participants n=8 Participants	6 Participants n=12 Participants	40 Participants n=68 Participants
ECOG Performance Status 2	2 Participants n=28 Participants	2 Participants n=20 Participants	0 Participants n=8 Participants	4 Participants n=12 Participants	8 Participants n=68 Participants
ECOG Performance Status 3	0 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	0 Participants n=68 Participants
ECOG Performance Status 4	0 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	0 Participants n=12 Participants	0 Participants n=68 Participants
Primary Disease Histology Adenocarcinoma	22 Participants n=28 Participants	18 Participants n=20 Participants	7 Participants n=8 Participants	6 Participants n=12 Participants	53 Participants n=68 Participants
Primary Disease Histology Squamous Cell Carcinoma	3 Participants n=28 Participants	2 Participants n=20 Participants	1 Participants n=8 Participants	2 Participants n=12 Participants	8 Participants n=68 Participants
Primary Disease Histology Large Cell Carcinoma	0 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	2 Participants n=12 Participants	2 Participants n=68 Participants
Primary Disease Histology Other	3 Participants n=28 Participants	0 Participants n=20 Participants	0 Participants n=8 Participants	2 Participants n=12 Participants	5 Participants n=68 Participants
Current Stage Locally Advanced	1 Participants n=28 Participants	1 Participants n=20 Participants	0 Participants n=8 Participants	1 Participants n=12 Participants	3 Participants n=68 Participants
Current Stage Metastatic	27 Participants n=28 Participants	19 Participants n=20 Participants	8 Participants n=8 Participants	11 Participants n=12 Participants	65 Participants n=68 Participants
Smoking History Lifetime Non-Smoker	10 Participants n=28 Participants	2 Participants n=20 Participants	3 Participants n=8 Participants	2 Participants n=12 Participants	17 Participants n=68 Participants
Smoking History Current Smoker	0 Participants n=28 Participants	4 Participants n=20 Participants	1 Participants n=8 Participants	3 Participants n=12 Participants	8 Participants n=68 Participants
Smoking History Past Smoker	18 Participants n=28 Participants	14 Participants n=20 Participants	4 Participants n=8 Participants	7 Participants n=12 Participants	43 Participants n=68 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Population: Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=12 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=28 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=20 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=8 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Objective Response Rate	0.0 percentage of participants Interval 0.0 to 26.46	10.7 percentage of participants Interval 2.27 to 28.23	15.0 percentage of participants Interval 3.21 to 37.89	25.0 percentage of participants Interval 3.19 to 65.09	—	—	—

SECONDARY outcome

Timeframe: From date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD, assessed up to 24 months.

Population: Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265

Duration of Response (DR) will be defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=3 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=3 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=2 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Duration of Response	—	85 days Interval 82.0 to 132.0	170 days Interval 120.0 to 170.0	NA days Interval 77.0 to Median DR and upper bound of 95% CI for median DR are not estimable. Median not reached/small number of events.	—	—	—

SECONDARY outcome

Timeframe: The time from date of first study treatment to first PD or death due to any cause in the absence of documented PD, up to 24 months.

Population: Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265

Progression-free survival (PFS) will be defined as the time from date of first study treatment to first PD or death due to any cause in the absence of documented PD. Per RECIST 1.1, Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=12 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=28 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=20 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=8 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Progression Free Survival	2.76 months Interval 1.48 to 4.01	3.95 months Interval 2.11 to 4.18	4.84 months Interval 1.35 to 5.53	3.39 months Interval 1.28 to Upper bound of 95% CI for median PFS is not estimable due to small number of events.	—	—	—

SECONDARY outcome

Timeframe: From date of first study treatment to death due to any cause, assessed up to 12 months

Population: Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265

1-Year Survival will be defined as the probability of survival at 1 year after the first dose.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=12 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=28 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=20 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=8 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
1-Year Survival Rate	13.89 percentage Interval 0.86 to 44.05	50.47 percentage Interval 27.49 to 69.62	34.92 percentage Interval 14.05 to 56.89	54.69 percentage Interval 13.72 to 83.24	—	—	—

SECONDARY outcome

Timeframe: From date of first study treatment to death due to any cause, assessed up to 24 months.

Population: Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265

Overall Survival will be defined as the time from date of first study treatment to death due to any cause

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=12 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=28 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=20 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=8 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Overall Survival	4.08 months Interval 1.22 to 11.05	16.32 months Interval 4.01 to Upper bound of 95% CI for median OS is not estimable due to small number of events.	7.04 months Interval 1.84 to 14.93	NA months Interval 0.89 to Median OS and upper bound of 95% CI for median OS are not estimable. Median not reached/small number of events.	—	—	—

SECONDARY outcome

Timeframe: Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.

Population: Safety population

Number of patients experiencing treatment-emergent adverse events.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=12 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=28 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=20 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=8 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Number of Patients Experiencing Treatment-emergent Adverse Events	12 Participants	28 Participants	20 Participants	8 Participants	—	—	—

SECONDARY outcome

Timeframe: Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.

Population: PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.

Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=13 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=46 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=30 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=17 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Blood Plasma Concentration of MGCD265 - AUC0-6	1837 h*ng/mL Geometric Coefficient of Variation 51.3	250.8 h*ng/mL Geometric Coefficient of Variation 98.0	1565 h*ng/mL Geometric Coefficient of Variation 54.0	185.5 h*ng/mL Geometric Coefficient of Variation 98.8	—	—	—

SECONDARY outcome

Timeframe: Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).

Population: PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule).

Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. On Cycle 2, samples were collected on Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). Note: Assessment of Cmax and Tmax are limited by the sparse blood sampling schedule post dose (i.e., only 2 blood draws post-dose in Cycle 1 and only 1 sample collected post-dose in Cycle 2). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=13 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=46 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=30 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=17 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 n=29 Participants Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 n=5 Participants Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 n=3 Participants Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Blood Plasma Concentration of MGCD265 - Cmax	328.1 ng/mL Geometric Coefficient of Variation 49.8	69.77 ng/mL Geometric Coefficient of Variation 87.1	279.2 ng/mL Geometric Coefficient of Variation 54.6	60.49 ng/mL Geometric Coefficient of Variation 103.9	214 ng/mL Geometric Coefficient of Variation 69.4	138 ng/mL Geometric Coefficient of Variation 100.0	386 ng/mL Geometric Coefficient of Variation 13.9

SECONDARY outcome

Timeframe: Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).

Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. On Cycle 2, samples were collected on Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=15 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=36 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 n=35 Participants Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 n=5 Participants Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 n=8 Participants Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Blood Plasma Concentration of MGCD265 - Ctrough	337 ng/mL Geometric Coefficient of Variation 59.2	—	264 ng/mL Geometric Coefficient of Variation 52.5	—	203 ng/mL Geometric Coefficient of Variation 80.9	255 ng/mL Geometric Coefficient of Variation 37.5	345 ng/mL Geometric Coefficient of Variation 48.5

SECONDARY outcome

Timeframe: Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.

Population: PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=13 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=30 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6	9.88 ratio Geometric Coefficient of Variation 96.4	—	6.42 ratio Geometric Coefficient of Variation 87.2	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.

Population: PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=13 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=30 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax	5.35 ratio Geometric Coefficient of Variation 100.9	—	4.07 ratio Geometric Coefficient of Variation 79.7	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.

Population: PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=13 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=30 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio	1.08 ratio Geometric Coefficient of Variation 10.4	—	1.09 ratio Geometric Coefficient of Variation 13.4	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.

Population: PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.

Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Note: Assessment of Cmax and Tmax are limited by the sparse blood sampling schedule post dose (i.e., only 2 blood draws post-dose in Cycle 1 and only 1 sample collected post-dose in Cycle 2). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=13 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=46 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=30 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=17 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Blood Plasma Concentration of MGCD265 - Tmax	6.00 hours Interval 2.0 to 6.0	6.00 hours Interval 2.0 to 6.0	2.00 hours Interval 2.0 to 6.0	6.00 hours Interval 6.0 to 6.0	—	—	—

SECONDARY outcome

Timeframe: At baseline

Only a sub-set of patients had different molecular techniques completed, therefore a correlation analysis was not performed. Patients with positive identification by two different analytical techniques are tabulated for MET Activating Mutations.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=11 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations Positive by both PCR and NGS	—	9 Participants	—	—	—	—	—
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations Positive by PCR and Negative by NGS	—	1 Participants	—	—	—	—	—
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations Negative by PCR and Positive by NGS	—	1 Participants	—	—	—	—	—
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations Negative by both PCR and NGS	—	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: At baseline

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=21 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications Positive by both FISH and NGS	—	8 Participants	—	—	—	—	—
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications Positive by FISH and Negative by NGS	—	6 Participants	—	—	—	—	—
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications Negative by FISH and Positive by NGS	—	7 Participants	—	—	—	—	—
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications Negative by both FISH and NGS	—	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: At baseline and at time of confirmation of response to treatment

Population: The study was closed early due to sponsor portfolio prioritization and not due to any patient safety issues. Based on limited individual patient data for whom baseline and post-treatment values were available, the statistical analyses as planned could not be performed. Screening and end of treatment detection results provided.

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=2 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=2 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population Detected at Screening	—	2 participants	2 participants	—	—	—	—
Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population Detected at End of Treatment	—	2 participants	1 participants	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 2

Population: The Pharmacodynamics Evaluable Population Population defined as all patients in the mITT population for whom PD analytical results were available. Overall number of participants analyzed at baseline and post-baseline are different due to samples not being collected post-baseline for some patients.

MET Activating Mutations in ctDNA. Change from Baseline - Cycle 2 Day 15 - Pre-Dose Standard Deviation not evaluable

Outcome measures

Outcome measures
Measure	MET Gene Amplifications in ctDNA n=9 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	MET Activating Mutations in Tumor Tissue n=22 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=17 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=4 Participants MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	Tablet 750 mg BID C2D1 Tablet formulation, 750 mg, BID, Cycle 2 Day 1	Tablet 750 mg BID C2D15 Tablet formulation, 750 mg, BID, Cycle 2 Day 15	Soft Gel 1050 mg BID C2D1 Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Blood Plasma Concentration of Soluble MET (sMET) Biomarker Baseline	961383.1 pg/mL Standard Deviation 1665608.92	443494.7 pg/mL Standard Deviation 228345.48	461985.2 pg/mL Standard Deviation 122069.25	450112.5 pg/mL Standard Deviation 80809.29	—	—	—
Blood Plasma Concentration of Soluble MET (sMET) Biomarker Actual - Cycle 1 Day 15 - Pre-Dose	775242.8 pg/mL Standard Deviation 679349.02	577631.4 pg/mL Standard Deviation 221350.47	568938.8 pg/mL Standard Deviation 129859.54	594277.3 pg/mL Standard Deviation 49746.18	—	—	—
Blood Plasma Concentration of Soluble MET (sMET) Biomarker Change from Baseline - Cycle 1 Day 15 - Pre-Dose	-257537.5 pg/mL Standard Deviation 1102955.10	122074.7 pg/mL Standard Deviation 166978.07	94110.4 pg/mL Standard Deviation 87158.09	144164.8 pg/mL Standard Deviation 51740.94	—	—	—
Blood Plasma Concentration of Soluble MET (sMET) Biomarker Actual - Cycle 2 Day 1 - Pre-Dose	742344.9 pg/mL Standard Deviation 620417.99	560790.3 pg/mL Standard Deviation 216802.34	582800.9 pg/mL Standard Deviation 140742.66	662385.3 pg/mL Standard Deviation 41039.78	—	—	—
Blood Plasma Concentration of Soluble MET (sMET) Biomarker Change from Baseline - Cycle 2 Day 1 - Pre-Dose	-219038.2 pg/mL Standard Deviation 1085522.39	144802.6 pg/mL Standard Deviation 158943.04	120815.6 pg/mL Standard Deviation 133979.33	212272.8 pg/mL Standard Deviation 86344.15	—	—	—
Blood Plasma Concentration of Soluble MET (sMET) Biomarker Actual - Cycle 2 Day 15 - Pre-Dose	628011.8 pg/mL Standard Deviation 291532.85	551625.9 pg/mL Standard Deviation 234249.28	630505.5 pg/mL Standard Deviation 133180.58	482109.0 pg/mL	—	—	—
Blood Plasma Concentration of Soluble MET (sMET) Biomarker Change from Baseline - Cycle 2 Day 15 - Pre-Dose	184161.0 pg/mL Standard Deviation 161224.04	96641.3 pg/mL Standard Deviation 144021.14	169374.6 pg/mL Standard Deviation 70996.25	44093.0 pg/mL	—	—	—

Adverse Events

MET Activating Mutations in Tumor Tissue

Serious events: 12 serious events

Other events: 28 other events

Deaths: 12 deaths

MET Gene Amplifications in Tumor Tissue

Serious events: 10 serious events

Other events: 20 other events

Deaths: 14 deaths

MET Activating Mutations in ctDNA

Serious events: 4 serious events

Other events: 7 other events

Deaths: 3 deaths

MET Gene Amplifications in ctDNA

Serious events: 7 serious events

Other events: 12 other events

Deaths: 9 deaths

Total

Serious events: 33 serious events

Other events: 67 other events

Deaths: 38 deaths

Serious adverse events

Serious adverse events
Measure	MET Activating Mutations in Tumor Tissue n=28 participants at risk MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=20 participants at risk MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=8 participants at risk MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	MET Gene Amplifications in ctDNA n=12 participants at risk MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	Total n=68 participants at risk All patients
Cardiac disorders Myocardial Infarction	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Colitis	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Enterocolitis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Nausea	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Vomiting	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Asthenia	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Multiple organ dysfunction syndrome	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Hepatobiliary disorders Hepatic haemorrhage	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Herpes zoster	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Lower respiratory tract infection	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Pneumonia	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	15.0% 3/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	7.4% 5/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Dehydration	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	15.0% 3/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 3/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.8% 6/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	17.9% 5/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 5/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	33.3% 4/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	22.1% 15/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Cerebrovascular accident	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Haemorrhage intracranial	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Seizure	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Syncope	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Renal and urinary disorders Acute kidney injury	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Bronchial fistula	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Oesophagobronchial fistula	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Vascular disorders Hypotension	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Vascular disorders Thrombosis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.

Other adverse events

Other adverse events
Measure	MET Activating Mutations in Tumor Tissue n=28 participants at risk MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.	MET Gene Amplifications in Tumor Tissue n=20 participants at risk MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.	MET Activating Mutations in ctDNA n=8 participants at risk MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).	MET Gene Amplifications in ctDNA n=12 participants at risk MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).	Total n=68 participants at risk All patients
Metabolism and nutrition disorders Hypocalcaemia	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	16.7% 2/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.3% 7/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Tremor	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Psychiatric disorders Agitation	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Psychiatric disorders Anxiety	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Psychiatric disorders Confusional state	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Psychiatric disorders Dysphemia	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Psychiatric disorders Insomnia	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Renal and urinary disorders Dysuria	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Renal and urinary disorders Haematuria	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Renal and urinary disorders Oliguria	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Renal and urinary disorders Urinary hesitation	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Renal and urinary disorders Urinary tract disorder	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Cough	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	30.0% 6/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	37.5% 3/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	19.1% 13/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	21.4% 6/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	40.0% 8/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	33.3% 4/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	29.4% 20/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 3/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.9% 4/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	16.7% 2/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.3% 7/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Productive cough	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.9% 4/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Skin and subcutaneous tissue disorders Alopecia	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Skin and subcutaneous tissue disorders Decubitus ulcer	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Skin and subcutaneous tissue disorders Pruritus	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Skin and subcutaneous tissue disorders Rash	14.3% 4/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	15.0% 3/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	11.8% 8/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Skin and subcutaneous tissue disorders Rash erythematous	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Vascular disorders Deep vein thrombosis	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Vascular disorders Embolism	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Vascular disorders Haemorrhage	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Vascular disorders Hot flush	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Vascular disorders Hypertension	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Vascular disorders Hypotension	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Vascular disorders Superior vena cava syndrome	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Vascular disorders Thrombosis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Malaise	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Non-cardiac chest pain	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Hypoalbuminaemia	14.3% 4/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 3/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	14.7% 10/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Blood and lymphatic system disorders Anaemia	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.8% 6/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Blood and lymphatic system disorders Leukocytosis	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Blood and lymphatic system disorders Thrombocytopenia	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Cardiac disorders Sinus tachycardia	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Cardiac disorders Tachycardia	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Eye disorders Cataract	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Eye disorders Eye discharge	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Eye disorders Periorbital oedema	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Eye disorders Vision blurred	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Eye disorders Visual impairment	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Abdominal distension	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Abdominal pain	17.9% 5/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	33.3% 4/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	17.6% 12/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Abdominal pain upper	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	7.4% 5/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Constipation	14.3% 4/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 3/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	14.7% 10/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Diarrhoea	78.6% 22/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	90.0% 18/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	87.5% 7/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	83.3% 10/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	83.8% 57/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Dry mouth	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Duodenal perforation	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Dyspepsia	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Dysphagia	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.9% 4/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Flatulence	17.9% 5/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.3% 7/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Gastrooesophageal reflux disease	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Haematochezia	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Nausea	53.6% 15/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	45.0% 9/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	75.0% 6/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	50.0% 6/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	52.9% 36/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Oesophagitis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Gastrointestinal disorders Vomiting	25.0% 7/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	40.0% 8/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	75.0% 6/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	50.0% 6/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	39.7% 27/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Asthenia	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	15.0% 3/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.3% 7/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Catheter site pain	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Chest discomfort	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Chest pain	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Face oedema	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Fatigue	46.4% 13/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	40.0% 8/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	62.5% 5/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	58.3% 7/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	48.5% 33/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders General physical health deterioration	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Oedema	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Oedema peripheral	28.6% 8/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 5/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	37.5% 3/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	23.5% 16/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Pain	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	15.0% 3/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.9% 4/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Peripheral swelling	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.9% 4/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
General disorders Pyrexia	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Hepatobiliary disorders Hepatic failure	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Hepatobiliary disorders Perforation bile duct	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Aspergillus infection	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Bronchitis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Clostridium difficile infection	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Conjunctivitis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Diverticulitis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Influenza	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Lower respiratory tract infection	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Lung infection	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Mucosal infection	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Oral candidiasis	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Pneumonia	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.9% 4/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Respiratory tract infection	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Sinusitis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Infections and infestations Urinary tract infection	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Injury, poisoning and procedural complications Contusion	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Injury, poisoning and procedural complications Fall	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Injury, poisoning and procedural complications Joint injury	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Injury, poisoning and procedural complications Laceration	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Alanine aminotransferase increased	50.0% 14/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	40.0% 8/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	37.5% 3/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	41.7% 5/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	44.1% 30/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Aspartate aminotransferase increased	42.9% 12/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	45.0% 9/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	37.5% 3/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	33.3% 4/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	41.2% 28/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Blood creatine increased	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Blood alkaline phosphatase	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Blood alkaline phosphatase increased	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	15.0% 3/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	11.8% 8/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Blood lactate dehydrogenase increased	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Blood magnesium decreased	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Capillary nail refill test abnormal	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Haemoglobin	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Inflammatory marker increased	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations International normalised ratio increased	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Lymphocyte count decreased	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Neutrophil count decreased	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.9% 4/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Platelet count decreased	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.8% 6/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Platelet count increased	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Transaminases increased	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Weight decreased	14.3% 4/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.9% 4/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations Weight increased	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Investigations White blood cell count decreased	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Decreased appetite	42.9% 12/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	30.0% 6/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	37.5% 3/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	33.3% 4/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	36.8% 25/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Dehydration	21.4% 6/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	13.2% 9/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Hyperkalaemia	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Hypokalaemia	17.9% 5/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 5/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	16.7% 2/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	19.1% 13/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Hypomagnesaemia	32.1% 9/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	20.0% 4/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	16.7% 2/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 17/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Hyponatraemia	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Metabolism and nutrition disorders Hypophosphataemia	17.9% 5/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.3% 7/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Arthralgia	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Back pain	10.7% 3/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.3% 7/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Flank pain	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.9% 4/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Joint swelling	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Muscle spasms	14.3% 4/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 5/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	14.7% 10/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	12.5% 1/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Pain in extremity	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.9% 4/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Musculoskeletal and connective tissue disorders Pain in jaw	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Dizziness	14.3% 4/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	15.0% 3/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	37.5% 3/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	14.7% 10/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Dysgeusia	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	25.0% 2/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	7.4% 5/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Headache	14.3% 4/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	10.0% 2/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.8% 6/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Hemiparesis	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Hypoaesthesia	3.6% 1/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Memory impairment	0.00% 0/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	5.0% 1/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	1.5% 1/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Neuropathy peripheral	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	2.9% 2/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
Nervous system disorders Paraesthesia	7.1% 2/28 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/20 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	0.00% 0/8 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	8.3% 1/12 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.	4.4% 3/68 • Up to 12 months All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.

Additional Information

Vanessa Tassell, Vice President, Clinical Science

Mirati Therapeutics, Inc.

Phone: 858-332-3438

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI can not disclose, discuss, or publish study results until final manuscript has been published.
Publication restrictions are in place

Restriction type: OTHER