Trial Outcomes & Findings for PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors (NCT NCT03149549)

Last Updated: 2024-01-05

Results Overview

All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

99 participants

Primary outcome timeframe

21 days for the Q3W schedule, 28 days for the Q2W schedule

Results posted on

2024-01-05

Participant Flow

The study was conducted in 4 parts (Part A, Part A2, Part B, and Part C1). Doses used were as follows: Parts A, A2, and B dosed 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 9, and 10 mg/kg every 21 days, and Part C1: 4 and 6 mg/kg dosed every 14 days. A2 biomarker cohorts and Cohort B are pooled with A cohorts receiving the identical dose and schedule. Study periods are reported as defined in the protocol.

Participant milestones

Participant milestones
Measure	A 0.25 mg/kg Q3W Part A 0.025 mg/kg Q3W	A 0.5 mg/kg Q3W Part A 0.5 mg/kg Q3W	A 1 mg/kg Q3W Part A 1mg/kg Q3W	A 2 mg/kg Q3W Part A 2 mg/kg Q3W	A, A2 4 mg/kg Q3W Parts A \& A2 4 mg/kg Q3W	A, A2 5 mg/kg Q3W Parts A \& A2 5 mg/kg Q3W	A, A2 6 mg/kg Q3W Parts A \& A2 6 mg/kg Q3W	A, A2, B 7 mg/kg Q3W Parts A, A2 \& B 7 mg/kg Q3W	A, A2 8 mg/kg Q3W Parts A \& A2 8 mg/kg Q3W	A, A2 9 mg/kg Q3W Parts A \& A2 9 mg/kg Q3W	A, A2 10 mg/kg Q3W Parts A \& A2 10 mg/kg Q3W	C1 4 mg/kg Q2W Part C1 4 mg/kg Q2W	C1 6 mg/kg Q2W Part C1 6 mg/kg Q2W
Study Discontinuation--Treatment Period STARTED	1	3	3	3	10	9	9	12	22	9	8	4	6
Study Discontinuation--Treatment Period COMPLETED	1	3	3	1	6	7	6	8	16	7	8	4	4
Study Discontinuation--Treatment Period NOT COMPLETED	0	0	0	2	4	2	3	4	6	2	0	0	2
Study Discontinuation--Follow-Up Period STARTED	1	3	3	1	6	7	6	8	16	7	8	4	4
Study Discontinuation--Follow-Up Period COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Study Discontinuation--Follow-Up Period NOT COMPLETED	1	3	3	1	6	7	6	8	16	7	8	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	A 0.25 mg/kg Q3W Part A 0.025 mg/kg Q3W	A 0.5 mg/kg Q3W Part A 0.5 mg/kg Q3W	A 1 mg/kg Q3W Part A 1mg/kg Q3W	A 2 mg/kg Q3W Part A 2 mg/kg Q3W	A, A2 4 mg/kg Q3W Parts A \& A2 4 mg/kg Q3W	A, A2 5 mg/kg Q3W Parts A \& A2 5 mg/kg Q3W	A, A2 6 mg/kg Q3W Parts A \& A2 6 mg/kg Q3W	A, A2, B 7 mg/kg Q3W Parts A, A2 \& B 7 mg/kg Q3W	A, A2 8 mg/kg Q3W Parts A \& A2 8 mg/kg Q3W	A, A2 9 mg/kg Q3W Parts A \& A2 9 mg/kg Q3W	A, A2 10 mg/kg Q3W Parts A \& A2 10 mg/kg Q3W	C1 4 mg/kg Q2W Part C1 4 mg/kg Q2W	C1 6 mg/kg Q2W Part C1 6 mg/kg Q2W
Study Discontinuation--Treatment Period Death	0	0	0	1	2	1	1	2	4	1	0	0	1
Study Discontinuation--Treatment Period Termination by Sponsor	0	0	0	0	0	0	0	1	0	0	0	0	1
Study Discontinuation--Treatment Period Withdrawal by Subject	0	0	0	1	2	1	2	0	2	0	0	0	0
Study Discontinuation--Treatment Period Other	0	0	0	0	0	0	0	1	0	1	0	0	0
Study Discontinuation--Follow-Up Period Lost to Follow-up	0	0	0	0	0	4	1	0	1	0	0	0	0
Study Discontinuation--Follow-Up Period Termination by Sponsor	0	0	0	0	1	0	0	1	5	0	0	3	2
Study Discontinuation--Follow-Up Period Withdrawal by Subject	0	0	0	0	1	0	0	4	1	1	3	0	1
Study Discontinuation--Follow-Up Period Other	0	0	0	0	0	0	0	0	0	1	0	0	0
Study Discontinuation--Follow-Up Period Death	1	3	3	1	4	3	5	3	9	5	5	1	1

Baseline Characteristics

PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A 0.25 mg/kg Q3W n=1 Participants Part A 0.25 mg/kg Q3W	A 0.5 mg/kg Q3W n=3 Participants Part A 0.5 mg/kg Q3W	A 1 mg/kg Q3W n=3 Participants Part A 1 mg/kg Q3W	A 2 mg/kg Q3W n=3 Participants Part A 2 mg/kg Q3W	A, A2 4 mg/kg Q3W n=10 Participants Parts A \& A2 4 mg/kg Q3W	A, A2 5 mg/kg Q3W n=9 Participants Parts A \& A2 5 mg/kg Q3W	A, A2 6 mg/kg Q3W n=9 Participants Parts A \& A2 6 mg/kg Q3W	A, A2 7 mg/kg Q3W n=12 Participants Parts A \& A2 7 mg/kg Q3W	A, A2 8 mg/kg Q3W n=22 Participants Parts A \& A2 8 mg/kg Q3W	A, A2 9 mg/kg Q3W n=9 Participants Parts A \& A2 9 mg/kg Q3W	A, A2 10 mg/kg Q3W n=8 Participants Parts A \& A2 10 mg/kg Q3W	C1 4 mg/kg Q2W n=4 Participants Part C1 4 mg/kg Q2W	C1 6 mg/kg Q2W n=6 Participants Part C1 6 mg/kg Q2W	Total n=99 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	60 years n=7 Participants	59 years n=5 Participants	68 years n=4 Participants	68 years n=21 Participants	49 years n=8 Participants	62 years n=8 Participants	59 years n=24 Participants	56.5 years n=42 Participants	56 years n=42 Participants	54 years n=42 Participants	59.5 years n=42 Participants	53.5 years n=36 Participants	59 years n=36 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants	7 Participants n=8 Participants	6 Participants n=8 Participants	12 Participants n=24 Participants	18 Participants n=42 Participants	7 Participants n=42 Participants	7 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=36 Participants	78 Participants n=36 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants	21 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	8 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants	7 Participants n=8 Participants	8 Participants n=8 Participants	9 Participants n=24 Participants	20 Participants n=42 Participants	7 Participants n=42 Participants	7 Participants n=42 Participants	4 Participants n=42 Participants	6 Participants n=36 Participants	86 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	5 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	5 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants	8 Participants n=8 Participants	8 Participants n=8 Participants	6 Participants n=24 Participants	17 Participants n=42 Participants	7 Participants n=42 Participants	7 Participants n=42 Participants	4 Participants n=42 Participants	6 Participants n=36 Participants	81 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	3 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	4 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	6 Participants n=36 Participants

PRIMARY outcome

Timeframe: 21 days for the Q3W schedule, 28 days for the Q2W schedule

Population: A DLT-evaluable subject is defined as one having received at least 1 dose of CX-2009 (or CX 2009 and CX-072) and then having completed the full DLT observation period (either 21 or 28 days depending on the schedule), or one who subsequently withdrew due to a drug-related toxicity.

Outcome measures

Outcome measures
Measure	A 0.25 mg/kg Q3W n=1 Participants Part A 0.25 mg/kg Q3W	A 0.5 mg/kg Q3W n=3 Participants Part A 0.5 mg/kg Q3W	A 1 mg/kg Q3W n=3 Participants Part A 1 mg/kg Q3W	A 2 mg/kg Q3W n=3 Participants Part A 2 mg/kg Q3W	A, A2 4 mg/kg Q3W n=10 Participants Parts A \& A2 4 mg/kg Q3W	A, A2 5 mg/kg Q3W n=9 Participants Parts A \& A2 5 mg/kg Q3W	A, A2 6 mg/kg Q3W n=9 Participants Parts A \& A2 6 mg/kg Q3W	A, A2, B 7 mg/kg Q3W n=12 Participants Parts A, A2 \& B 7 mg/kg Q3W	A, A2 8 mg/kg Q3W n=22 Participants Parts A \& A2 8 mg/kg Q3W	A, A2 9 mg/kg Q3W n=9 Participants Parts A \& A2 9 mg/kg Q3W	A, A2 10 mg/kg Q3W n=8 Participants Parts A \& A2 10 mg/kg Q3W	C1 4 mg/kg Q2W n=4 Participants Part C1 4 mg/kg Q2W	C1 6 mg/kg Q2W n=6 Participants Part C1 6 mg/kg Q2W
The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy Participants not experiencing DLTs	1 Participants	3 Participants	3 Participants	3 Participants	10 Participants	9 Participants	9 Participants	12 Participants	21 Participants	9 Participants	8 Participants	4 Participants	4 Participants
The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy Participants experiencing DLT	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Median total on-study follow-up of 18.4 weeks.

Population: The response evaluable population includes all subjects in the safety analysis population who have an adequate baseline disease assessment and at least one post-baseline disease assessment.

Efficacy will be assessed via objective response rate (ORR) by RECIST version 1.1. ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) on two consecutive tumor assessments with scan dates at least 4 weeks apart according to RECIST (version 1.1, refer to SAP section 13.1.1). Complete criteria for RECIST 1.1 are provided as an appendix to the protocol. \> \> For as long as a subject continues follow-up for response in the study, CT/MRI/Tumor assessment are to be conducted every 8 (+/- 1) weeks from the first dose of CX 2009 with assessment for response per \> RECIST Version 1.1

Outcome measures

Outcome measures
Measure	A 0.25 mg/kg Q3W n=1 Participants Part A 0.25 mg/kg Q3W	A 0.5 mg/kg Q3W n=1 Participants Part A 0.5 mg/kg Q3W	A 1 mg/kg Q3W n=3 Participants Part A 1 mg/kg Q3W	A 2 mg/kg Q3W n=3 Participants Part A 2 mg/kg Q3W	A, A2 4 mg/kg Q3W n=9 Participants Parts A \& A2 4 mg/kg Q3W	A, A2 5 mg/kg Q3W n=7 Participants Parts A \& A2 5 mg/kg Q3W	A, A2 6 mg/kg Q3W n=7 Participants Parts A \& A2 6 mg/kg Q3W	A, A2, B 7 mg/kg Q3W n=10 Participants Parts A, A2 \& B 7 mg/kg Q3W	A, A2 8 mg/kg Q3W n=18 Participants Parts A \& A2 8 mg/kg Q3W	A, A2 9 mg/kg Q3W n=6 Participants Parts A \& A2 9 mg/kg Q3W	A, A2 10 mg/kg Q3W n=5 Participants Parts A \& A2 10 mg/kg Q3W	C1 4 mg/kg Q2W n=4 Participants Part C1 4 mg/kg Q2W	C1 6 mg/kg Q2W n=6 Participants Part C1 6 mg/kg Q2W
Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

Adverse Events

Part A 0.25 mg/kg Q3W

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Part A 0.5 mg/kg Q3W

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Part A 1 mg/kg Q3W

Serious events: 0 serious events

Other events: 2 other events

Deaths: 3 deaths

Part A 2 mg/kg Q3W

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Parts A & A2 4 mg/kgQ3W (4 in Part A, 6 inPart A2)

Serious events: 2 serious events

Other events: 10 other events

Deaths: 6 deaths

Parts A & A2 5 mg/kgQ3W (3 in Part A, 6 inPart A2)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 4 deaths

Parts A & A2 6 mg/kgQ3W (3 in Part A, 6 inPart A2)

Serious events: 3 serious events

Other events: 9 other events

Deaths: 6 deaths

Parts A, A2 & B 7mg/kg Q3W (3 in PartA, 6 in Part A2, 3 inPart B)

Serious events: 5 serious events

Other events: 12 other events

Deaths: 6 deaths

Parts A & A2 8 mg/kgQ3W (16 in Part A, 6 inPart A2)

Serious events: 10 serious events

Other events: 22 other events

Deaths: 13 deaths

Parts A & A2 9 mg/kgQ3W (3 in Part A, 6 inPart A2)

Serious events: 5 serious events

Other events: 9 other events

Deaths: 7 deaths

Parts A & A2 10 mg/kgQ3W (5 in Part A, 3 inPart A2)

Serious events: 3 serious events

Other events: 8 other events

Deaths: 6 deaths

Part C1 4 mg/kg Q2W

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Part C1 6 mg/kg Q2W

Serious events: 1 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Part A 0.25 mg/kg Q3W n=1 participants at risk A 0.25 mg/kg (Q3W)	Part A 0.5 mg/kg Q3W n=3 participants at risk A 0.5 mg/kg (Q3W)	Part A 1 mg/kg Q3W n=3 participants at risk A 1 mg/kg (Q3W)	Part A 2 mg/kg Q3W n=3 participants at risk A 2 mg/kg (Q3W)	Parts A & A2 4 mg/kgQ3W (4 in Part A, 6 inPart A2) n=10 participants at risk A, A2 4 mg/kg Q3W	Parts A & A2 5 mg/kgQ3W (3 in Part A, 6 inPart A2) n=9 participants at risk A, A2 5 mg/kg Q3W	Parts A & A2 6 mg/kgQ3W (3 in Part A, 6 inPart A2) n=9 participants at risk A, A2 6 mg/kg Q3W	Parts A, A2 & B 7mg/kg Q3W (3 in PartA, 6 in Part A2, 3 inPart B) n=12 participants at risk A, A2, B 7 mg/kg Q3W	Parts A & A2 8 mg/kgQ3W (16 in Part A, 6 inPart A2) n=22 participants at risk A, A2 8 mg/kg Q3W	Parts A & A2 9 mg/kgQ3W (3 in Part A, 6 inPart A2) n=9 participants at risk A, A2 9 mg/kg Q3W	Parts A & A2 10 mg/kgQ3W (5 in Part A, 3 inPart A2) n=8 participants at risk A, A2 10 mg/kg Q3W	Part C1 4 mg/kg Q2W n=4 participants at risk C1 4 mg/kg Q2W	Part C1 6 mg/kg Q2W n=6 participants at risk C1 6 mg/kg Q2W
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Cardiac disorders Cardiac tamponade	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Cardiac disorders Pericardial effusion	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Ear and labyrinth disorders Ear pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Keratitis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Constipation	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Nausea	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Vomiting	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders General physical health deterioration	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Non-cardiac chest pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Hepatobiliary disorders Cholangitis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Catheter site infection	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Cellulitis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Cellulitis orbital	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Device related infection	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Herpes zoster	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Large intestine infection	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Pneumonia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Sepsis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Septic shock	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Neutrophil count decreased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Haemorrhagic stroke	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Intracranial haematoma	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Neuropathy peripheral	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Neurotoxicity	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Seizure	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Vascular disorders Embolism	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.

Other adverse events

Other adverse events
Measure	Part A 0.25 mg/kg Q3W n=1 participants at risk A 0.25 mg/kg (Q3W)	Part A 0.5 mg/kg Q3W n=3 participants at risk A 0.5 mg/kg (Q3W)	Part A 1 mg/kg Q3W n=3 participants at risk A 1 mg/kg (Q3W)	Part A 2 mg/kg Q3W n=3 participants at risk A 2 mg/kg (Q3W)	Parts A & A2 4 mg/kgQ3W (4 in Part A, 6 inPart A2) n=10 participants at risk A, A2 4 mg/kg Q3W	Parts A & A2 5 mg/kgQ3W (3 in Part A, 6 inPart A2) n=9 participants at risk A, A2 5 mg/kg Q3W	Parts A & A2 6 mg/kgQ3W (3 in Part A, 6 inPart A2) n=9 participants at risk A, A2 6 mg/kg Q3W	Parts A, A2 & B 7mg/kg Q3W (3 in PartA, 6 in Part A2, 3 inPart B) n=12 participants at risk A, A2, B 7 mg/kg Q3W	Parts A & A2 8 mg/kgQ3W (16 in Part A, 6 inPart A2) n=22 participants at risk A, A2 8 mg/kg Q3W	Parts A & A2 9 mg/kgQ3W (3 in Part A, 6 inPart A2) n=9 participants at risk A, A2 9 mg/kg Q3W	Parts A & A2 10 mg/kgQ3W (5 in Part A, 3 inPart A2) n=8 participants at risk A, A2 10 mg/kg Q3W	Part C1 4 mg/kg Q2W n=4 participants at risk C1 4 mg/kg Q2W	Part C1 6 mg/kg Q2W n=6 participants at risk C1 6 mg/kg Q2W
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	13.6% 3/22 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	20.0% 2/10 • Number of events 6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 2/12 • Number of events 6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.7% 5/22 • Number of events 13 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 2/6 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Cardiac disorders Pericardial effusion	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Ear and labyrinth disorders Ear disorder	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Ear and labyrinth disorders Tinnitus	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Endocrine disorders Hypothyroidism	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Endocrine disorders Primary adrenal insufficiency	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Asthenopia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Astigmatism	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Cataract	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Chalazion	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Corneal infiltrates	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Dry eye	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	50.0% 2/4 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Eye pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Eyelid ptosis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Keratitis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	31.8% 7/22 • Number of events 13 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	50.0% 4/8 • Number of events 11 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 4/6 • Number of events 16 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Keratopathy	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Orbital cyst	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Photophobia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Presbyopia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Punctate keratitis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Pupillary reflex impaired	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Retinal degeneration	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Vision blurred	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	30.0% 3/10 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.7% 5/22 • Number of events 6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	62.5% 5/8 • Number of events 6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Eye disorders Visual impairment	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 2/12 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.7% 5/22 • Number of events 7 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Ascites	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	20.0% 2/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Constipation	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 2/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	20.0% 2/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 4/12 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	18.2% 4/22 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	50.0% 3/6 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 2/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 2/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 3/9 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 2/12 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	31.8% 7/22 • Number of events 9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	44.4% 4/9 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	37.5% 3/8 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	50.0% 2/4 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Dry mouth	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	13.6% 3/22 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 2/8 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Flatulence	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Alanine aminotransferase increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 3/9 • Number of events 9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	31.8% 7/22 • Number of events 16 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 2/8 • Number of events 12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 2/6 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Gastritis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Gingival bleeding	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Nausea	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	60.0% 6/10 • Number of events 7 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	44.4% 4/9 • Number of events 8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	50.0% 6/12 • Number of events 7 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	50.0% 11/22 • Number of events 13 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 6/9 • Number of events 7 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	75.0% 6/8 • Number of events 7 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 2/6 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Odynophagia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Proctalgia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Toothache	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Gastrointestinal disorders Vomiting	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	30.0% 3/10 • Number of events 6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 3/12 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	27.3% 6/22 • Number of events 9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	37.5% 3/8 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Asthenia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Chest pain	100.0% 1/1 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Chills	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Fatigue	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 2/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	30.0% 3/10 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 6/9 • Number of events 8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 6/9 • Number of events 8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	58.3% 7/12 • Number of events 8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	45.5% 10/22 • Number of events 15 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	44.4% 4/9 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 2/8 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	50.0% 3/6 • Number of events 6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Feeling cold	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Gait disturbance	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Infusion site erythema	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Infusion site phlebitis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Malaise	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Mucosal inflammation	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Non-cardiac chest pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Oedema	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Oedema peripheral	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 2/12 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	13.6% 3/22 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Peripheral swelling	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Pyrexia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 2/3 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 4/12 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	75.0% 3/4 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
General disorders Secretion discharge	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Immune system disorders Seasonal allergy	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Adenoviral conjunctivitis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Candida infection	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Cellulitis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Conjunctivitis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Lip infection	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Pneumonia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Pneumonia viral	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Stoma site infection	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Infections and infestations Urinary tract infection	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 4/12 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Injury, poisoning and procedural complications Concussion	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 2/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 3/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 2/12 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.7% 5/22 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	50.0% 2/4 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 2/6 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Injury, poisoning and procedural complications Oral contusion	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Ammonia increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 3/9 • Number of events 8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	40.9% 9/22 • Number of events 32 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	37.5% 3/8 • Number of events 14 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 2/6 • Number of events 7 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.7% 5/22 • Number of events 7 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Blood calcium increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Blood creatine increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Blood creatinine increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 3/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Blood glucose increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Blood iron decreased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Gamma-glutamyltransferase increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations International normalised ratio increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Lymphocyte count decreased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Platelet count decreased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Transaminases increased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations Weight decreased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	18.2% 4/22 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Investigations White blood cell count decreased	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 2/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	50.0% 5/10 • Number of events 7 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	44.4% 4/9 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 4/12 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	36.4% 8/22 • Number of events 9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	55.6% 5/9 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 2/8 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Fluid overload	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 4/12 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	44.4% 4/9 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 2/6 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	20.0% 2/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 2/12 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 3/9 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 2/8 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	30.0% 3/10 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 3/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 3/12 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	13.6% 3/22 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 1/1 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	20.0% 2/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 3/12 • Number of events 7 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	40.0% 4/10 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 3/9 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	18.2% 4/22 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	100.0% 1/1 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Myalgia	100.0% 1/1 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 2/12 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 2/6 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Dizziness	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	20.0% 2/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Dysaesthesia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Dysarthria	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Dysgeusia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Headache	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	13.6% 3/22 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 2/6 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Hypoaesthesia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Memory impairment	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Neuropathy peripheral	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 2/12 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	27.3% 6/22 • Number of events 8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 3/9 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	50.0% 3/6 • Number of events 9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Neurotoxicity	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Paraesthesia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Seizure	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Syncope	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Taste disorder	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Nervous system disorders Tremor	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Psychiatric disorders Anxiety	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	13.6% 3/22 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Psychiatric disorders Confusional state	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Psychiatric disorders Depression	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Psychiatric disorders Insomnia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 3/12 • Number of events 3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	18.2% 4/22 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 2/6 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	20.0% 2/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Renal and urinary disorders Bladder pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Renal and urinary disorders Dysuria	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Renal and urinary disorders Haematuria	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Renal and urinary disorders Micturition urgency	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Renal and urinary disorders Urinary incontinence	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Renal and urinary disorders Urinary tract pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Reproductive system and breast disorders Pelvic pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Allergic bronchitis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 2/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	40.0% 4/10 • Number of events 5 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 3/12 • Number of events 6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Pharyngeal hypoaesthesia	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Pulmonary pain	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Blister	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	16.7% 1/6 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	20.0% 2/10 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	22.2% 2/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	8.3% 1/12 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Surgical and medical procedures Tooth extraction	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Vascular disorders Deep vein thrombosis	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 2/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Vascular disorders Flushing	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	66.7% 2/3 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/22 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Vascular disorders Hot flush	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	10.0% 1/10 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Vascular disorders Hypertension	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	4.5% 1/22 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	12.5% 1/8 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/4 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.
Vascular disorders Hypotension	0.00% 0/1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/3 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	33.3% 1/3 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/10 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	11.1% 1/9 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/12 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	9.1% 2/22 • Number of events 2 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/9 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/8 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	25.0% 1/4 • Number of events 1 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.	0.00% 0/6 • AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks). Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable). Output for the all-cause mortality table includes deaths secondary to progression of disease.

Additional Information

Monika Vainorius

CytomX Therapeutics

Phone: (650) 515-3185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place