Trial Outcomes & Findings for Study of Avelumab-M3814 Combinations (NCT NCT03724890)

Last Updated: 2025-04-10

Results Overview

A DLT was defined as any Grade more than or equal to \>= 3 nonhematologic Adverse Event(AE) or any Grade\>= 4 hematologic,, occurring during the DLT period that is related to any of the study interventions. In addition, a DLT is considered: Grade 3 thrombocytopenia with medically concerning bleeding, Any febrile neutropenia. A study intervention-related Treatment emergent Adverse Event(TEAE) is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk. Any toxicity related to study intervention that causes the participant to receive less than 80% of M3814 during DLT period, evidence of study treatment-related hepatocellular injury for more than 3 days, such as\> 5-fold elevations above the Upper Limits of Normal (ULN) of Alanine Aminotransferase (ALT) or Aspartate Aminotransferase(AST) with or without elevation of serum total bilirubin to \> 2 × ULN. Number of Participants with DLT Grade \>= 3 were reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

57 participants

Primary outcome timeframe

Day 1 up to Day 21

Results posted on

2025-04-10

Participant Flow

First participant signed informed consent: 27-Nov-2018; Clinical data cutoff date: 05 Aug 2022

This study was conducted in 3 parts; Part A, Part B and Part Food Effect (FE). Participants who enrolled in Part A of study were not eligible to participate in Part B and Part FE.

Participant milestones

Participant milestones
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 100 mg BID + Avelumab 800 mg Q2W + RT Participants received 100 mg of M3814 along with radiotherapy (RT) at 3 grays (Gy) once daily (QD) starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 150 mg BID +Avelumab 800 mg Q2W + RT Participants received 150 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 200 mg BID + Avelumab 800 mg Q2W + RT Participants received 200 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 250 mg BID + Avelumab 800 mg Q2W + RT Participants received 250 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part Food Effect: M3814 100 mg BID + Avelumab 800 mg Q2W Participants were administered 100 mg M3814 tablet orally BID in combination with i.v of avelumab at a dose of 800 mg Q2W throughout the whole study under fasted condition with the exception of fed condition on Day 1 and Day 22. The summary statistics for demographics, safety and efficacy is based on dose level but not fast/fed condition which is not fit for purpose.	Part Food Effect: M3814 200 mg BID + Avelumab 800 mg Q2W Participants were administered 200 mg M3814 tablet orally BID in combination with i.v of avelumab at a dose of 800 mg Q2W throughout the whole study under fasted condition with the exception of fed condition on Day 1 and Day 22. The summary statistics for demographics, safety and efficacy is based on dose level but not fast/fed condition which is not fit for purpose.
Overall Study STARTED	4	11	4	6	4	3	3	4	9	4	5
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	11	4	6	4	3	3	4	9	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 100 mg BID + Avelumab 800 mg Q2W + RT Participants received 100 mg of M3814 along with radiotherapy (RT) at 3 grays (Gy) once daily (QD) starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 150 mg BID +Avelumab 800 mg Q2W + RT Participants received 150 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 200 mg BID + Avelumab 800 mg Q2W + RT Participants received 200 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 250 mg BID + Avelumab 800 mg Q2W + RT Participants received 250 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part Food Effect: M3814 100 mg BID + Avelumab 800 mg Q2W Participants were administered 100 mg M3814 tablet orally BID in combination with i.v of avelumab at a dose of 800 mg Q2W throughout the whole study under fasted condition with the exception of fed condition on Day 1 and Day 22. The summary statistics for demographics, safety and efficacy is based on dose level but not fast/fed condition which is not fit for purpose.	Part Food Effect: M3814 200 mg BID + Avelumab 800 mg Q2W Participants were administered 200 mg M3814 tablet orally BID in combination with i.v of avelumab at a dose of 800 mg Q2W throughout the whole study under fasted condition with the exception of fed condition on Day 1 and Day 22. The summary statistics for demographics, safety and efficacy is based on dose level but not fast/fed condition which is not fit for purpose.
Overall Study Death	2	6	3	5	2	0	2	3	4	2	2
Overall Study Lost to Follow-up	0	3	0	1	2	2	1	0	2	0	0
Overall Study Withdrawal by Subject	1	2	1	0	0	1	0	0	2	2	1
Overall Study Other	1	0	0	0	0	0	0	1	1	0	2

Baseline Characteristics

Study of Avelumab-M3814 Combinations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 100 mg BID + Avelumab 800 mg Q2W + RT n=3 Participants Participants received 100 mg of M3814 along with radiotherapy (RT) at 3 grays (Gy) once daily (QD) starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 150 mg BID +Avelumab 800 mg Q2W + RT n=3 Participants Participants received 150 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 200 mg BID + Avelumab 800 mg Q2W + RT n=4 Participants Participants received 200 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 250 mg BID + Avelumab 800 mg Q2W + RT n=9 Participants Participants received 250 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part Food Effect: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants were administered 100 mg M3814 tablet orally BID in combination with i.v of avelumab at a dose of 800 mg Q2W throughout the whole study under fasted condition with the exception of fed condition on Day 1 and Day 22. The summary statistics for demographics, safety and efficacy is based on dose level but not fast/fed condition which is not fit for purpose.	Part Food Effect: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants were administered 200 mg M3814 tablet orally BID in combination with i.v of avelumab at a dose of 800 mg Q2W throughout the whole study under fasted condition with the exception of fed condition on Day 1 and Day 22. The summary statistics for demographics, safety and efficacy is based on dose level but not fast/fed condition which is not fit for purpose.	Total n=57 Participants Total of all reporting groups
Age, Continuous	59 Years STANDARD_DEVIATION 17.5 • n=5 Participants	55 Years STANDARD_DEVIATION 19.6 • n=7 Participants	53 Years STANDARD_DEVIATION 18.6 • n=5 Participants	64 Years STANDARD_DEVIATION 4.1 • n=4 Participants	53 Years STANDARD_DEVIATION 7.7 • n=21 Participants	59 Years STANDARD_DEVIATION 17.3 • n=8 Participants	69 Years STANDARD_DEVIATION 13.8 • n=8 Participants	62 Years STANDARD_DEVIATION 7.2 • n=24 Participants	61 Years STANDARD_DEVIATION 8.6 • n=42 Participants	64 Years STANDARD_DEVIATION 9.3 • n=42 Participants	68 Years STANDARD_DEVIATION 17.3 • n=42 Participants	60 Years STANDARD_DEVIATION 13.8 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	32 Participants n=42 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	5 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	25 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants	8 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	54 Participants n=42 Participants
Ethnicity (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	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 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	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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 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	11 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	8 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	44 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	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
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	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

PRIMARY outcome

Timeframe: Day 1 up to Day 21

Population: DLT analysis set included all participants who received at least 34 of 42 daily doses of M3814 and 2 administrations of avelumab during the DLT evaluation period and remained on study for the entirety of the DLT evaluation period, or participants who experienced a DLT during the DLT evaluation period and received any amount of any study intervention. The DLT evaluation period was defined as the first 21 days of the study, following the start of study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=2 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Assessed Using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 28

Population: DLT analysis set included all participants who received 8 of 10 daily doses of peposertib, 8 fractions of radiotherapy, and 3 administrations of avelumab during the DLT evaluation period and remained on study for the entirety of the DLT evaluation period or participants who experienced a DLT during the DLT evaluation period and received any amount of any study intervention. The DLT evaluation period was defined as the first 28days of the study, following the start of study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Assessed Using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hours post-dose on Day 1; Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 15; Pre-dose, 2, 4 and 6 hours post-dose on Day 22

Population: The Pharmacokinetic (PK) Analysis Set included all subjects who received at least one administration of M3814 and avelumab and had at least one measurable post-dose PK sample. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Area under the plasma concentration versus time curve from time zero to 6 hours post dosing for M3814 was reported.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=2 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part Food Effect (FE): Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to 6 Hour (AUC0-6hour) of M3814 Day 22	NA hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values	NA hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values	—	—	—
Part Food Effect (FE): Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to 6 Hour (AUC0-6hour) of M3814 Day 1	1520 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 159.7	NA hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values	—	—	—
Part Food Effect (FE): Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to 6 Hour (AUC0-6hour) of M3814 Day 15	6250 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 86.4	NA hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hours post-dose on Day 1; Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 15; Pre-dose, 2, 4 and 6 hours post-dose on Day 22

Cmax was obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Maximum Observed Plasma Concentration (Cmax) of M3814 Day 1	563 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 100.5	950 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 119.6	—	—	—
Part FE: Maximum Observed Plasma Concentration (Cmax) of M3814 Day 15	1370 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 63.2	NA nanogram per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values	—	—	—
Part FE: Maximum Observed Plasma Concentration (Cmax) of M3814 Day 22	1070 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 99.4	NA nanogram per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values	—	—	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 516 days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

An Adverse Event(AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign, symptom, or disease associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. Serious AE: AE that resulted in death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to study intervention. Number of participants with TEAEs, treatment related TEAEs and serious TEAEs were reported.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-related TEAEs and Serious TEAEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 TEAEs	3 Participants	11 Participants	4 Participants	6 Participants	4 Participants
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-related TEAEs and Serious TEAEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Related TEAE	3 Participants	10 Participants	3 Participants	4 Participants	4 Participants
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-related TEAEs and Serious TEAEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Serious TEAE	0 Participants	6 Participants	4 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 513 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Number of Participants With Treatment-Emergent Adverse Events, Treatment-related TEAEs and Serious TEAEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 TEAEs	3 Participants	3 Participants	4 Participants	9 Participants	—
Part B: Number of Participants With Treatment-Emergent Adverse Events, Treatment-related TEAEs and Serious TEAEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Treatment-related TEAEs	3 Participants	3 Participants	4 Participants	8 Participants	—
Part B: Number of Participants With Treatment-Emergent Adverse Events, Treatment-related TEAEs and Serious TEAEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Serious TEAEs	2 Participants	1 Participants	1 Participants	6 Participants	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 404 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-related TEAEs and Serious TEAEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 TEAEs	4 Participants	5 Participants	—	—	—
Part FE: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-related TEAEs and Serious TEAEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Treatment-related TEAEs	3 Participants	5 Participants	—	—	—
Part FE: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-related TEAEs and Serious TEAEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Serious TEAEs	2 Participants	3 Participants	—	—	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 516 days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

The laboratory measurements included hematology and biochemistry values were graded with National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 toxicity grades (where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = death). Number of participants with abnormalities Grade \>= 3 in laboratory test values were reported.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Number of Participants With Abnormalities Grade Greater Than or Equals to (>=) 3 in Laboratory Test Values	0 Participants	7 Participants	4 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 513 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Number of Participants With Abnormalities Grade Greater Than or Equals to (>=) 3 in Laboratory Test Values	0 Participants	0 Participants	0 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 404 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Number of Participants With Abnormalities Grade Greater Than or Equals to (>=) 3 in Laboratory Test Values	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 516 days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Number of participants with clinically meaningful change from baseline in ECG parameters were reported. Clinically Meaningful Change was decided by the investigator. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 513 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 404 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 516 days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Number of participants with clinically meaningful change from baseline in vital signs. Clinically Meaningful Change was decided by the investigator. Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Number of Participants With Clinically Meaningful Change From Baseline in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 513 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Number of Participants With Clinically Meaningful Change From Baseline in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 404 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Number of Participants With Clinically Meaningful Change From Baseline in Vital Signs	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 516 days)

Population: Safety Analysis Set included all participants who receive at least one dose of any study intervention.

ECOG PS score is widely used by doctors and researchers to assess how a participants disease is progressing and is used to assess how the disease affects the daily living abilities of the participant and determine appropriate treatment and prognosis. The score ranges from Grade0 to Grade5, where Grade0=Fully active, able to carry on all pre-disease performance without restriction, Grade1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair, Grade5=Death.ECOG performance status was reported in terms of number of participants with baseline value vs worst post-baseline value.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score Missing	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 1	2 Participants	4 Participants	0 Participants	2 Participants	1 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 2	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 3	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score Missing	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 0	2 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 1	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 3	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 513 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 0	1 Participants	0 Participants	0 Participants	2 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 1	1 Participants	2 Participants	3 Participants	1 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 2	0 Participants	0 Participants	0 Participants	1 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 3	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 4	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 5	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score Missing	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 0	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 1	1 Participants	1 Participants	1 Participants	5 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 2	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 3	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 4	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 5	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B:Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score Missing	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 404 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 0	0 Participants	1 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 1	1 Participants	2 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 2	1 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 3	0 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 4	0 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 5	0 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score Missing	0 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 0	0 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 1	1 Participants	2 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 2	1 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 3	0 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 4	0 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 5	0 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score Missing	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 1

Population: The PK Analysis Set included all participants who received at least one administration of M3814 and avelumab and had at least one measurable post-dose PK sample. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Cmax was obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=10 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Single Dose: Maximum Observed Plasma Concentration (Cmax) of M3814	392 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 43.8	1030 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 78.2	2340 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 98.9	1710 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 99.8	3190 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 40.6

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 15

Cmax was obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of M3814	693 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 131.1	2370 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 38.8	NA nanogram per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	2360 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 33.6	NA nanogram per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1

Cmax was obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=2 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=8 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Single Dose: Maximum Observed Drug Concentration (Cmax) of M3814	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	1460 ng/mL Geometric Coefficient of Variation 19.0	854 ng/mL Geometric Coefficient of Variation 66.2	2380 ng/mL Geometric Coefficient of Variation 44.8	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 10

Cmax was obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=2 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Multiple Dose: Maximum Observed Drug Concentration (Cmax) of M3814	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	1220 ng/mL Geometric Coefficient of Variation 5.8	1420 ng/mL Geometric Coefficient of Variation 71.4	3150 ng/mL Geometric Coefficient of Variation 63.6	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 15

Population: PK Analysis Set included all participants who received at least 1 administration of peposertib and avelumab and had at least 1 measurable post-dose PK sample. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Tmax was obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=10 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Single Dose: Time to Reach the Maximum Plasma Concentration (Tmax) of M3814	1.06 hour Interval 1.0 to 1.12	2.02 hour Interval 0.85 to 6.0	1.03 hour Interval 0.87 to 2.08	1.51 hour Interval 0.88 to 2.17	1.08 hour Interval 1.0 to 2.05

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 15

Tmax was obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Multiple Dose: Time to Reach the Maximum Plasma Concentration (Tmax) of M3814	1.08 hour Interval 1.0 to 2.98	1.16 hour Interval 0.93 to 4.0	NA hour Median and Full Range could not be calculated if fewer than 3 participants had reportable parameter values.	1.87 hour Interval 1.03 to 2.08	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 4 and 6 hours post-dose on Day 10

Tmax was obtained directly from the concentration versus time curve postdose.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=2 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Single Dose: Time to Reach the Maximum Plasma Concentration (Tmax) of M3814	NA hour Median and Full range could not be calculated if fewer than 3 participants had reportable parameter values	0.93 hour Interval 0.85 to 1.0	1.42 hour Interval 0.87 to 2.25	1.47 hour Interval 0.72 to 3.82	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 4 and 6 hours post-dose on Day 10

Tmax was obtained directly from the concentration versus time curve postdose.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Multiple Dose: Time to Reach the Maximum Plasma Concentration (Tmax) of M3814	NA hour Median and Full Range could not be calculated if fewer than 3 participants had reportable parameter values.	2.18 hour Interval 1.98 to 2.78	2.28 hour Interval 1.88 to 2.5	2.01 hour Interval 1.85 to 5.03	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for Cmin was not collected.

Cmin is minimum observed plasma concentration obtained directly from the concentration versus time curve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for Cmin was not collected.

Cmin is minimum observed plasma concentration obtained directly from the concentration versus time curve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for Cavg was not collected.

Cavg is the average plasma concentration within 1 dosing interval obtained directly from the concentration versus time curve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for Cavg was not collected.

Cavg is the average plasma concentration within 1 dosing interval obtained directly from the concentration versus time curve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for Fluctuation Index was not collected.

Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100\*(\[Cmax Cmin\]/Cavg).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for Fluctuation Index was not collected.

Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100\*(\[Cmax Cmin\]/Cavg).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for AUC0-t was not collected.

Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for AUC0-t was not collected.

Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for AUC0-inf was not collected.

Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-inf calculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for AUC0-inf was not collected.

Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Days 1 and 15

Population: PK Analysis Set included all participants who received at least 1 administration of peposertib and avelumab and had at least 1 measurable post-dose PK sample. Here, Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Accumulation ratio of Cmax was calculated as Cmax, after dosing on Day 15 divided by Cmax, after dosing on Day 1.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Accumulation Ratio of Maximum Observed Drug Concentration [Racc(Cmax)] of M3814	1.77 ratio Geometric Coefficient of Variation 95.1	1.47 ratio Geometric Coefficient of Variation 28.7	NA ratio Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	2.61 ratio Geometric Coefficient of Variation 45.0	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1;Pre-dose, 2, 4 and 6 hours post-dose on Day 10

Population: PK Analysis Set included all participants who received at least 1 administration of peposertib and avelumab and had at least 1 measurable post-dose PK sample. Here, Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Accumulation ratio of Cmax was calculated as Cmax, after dosing on Day 10 divided by Cmax, after dosing on Day 1.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Accumulation Ratio of Cmax [Racc(Cmax)] of M3814	NA ratio Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	0.838 ratio Geometric Coefficient of Variation 24.8	2.15 ratio Geometric Coefficient of Variation 30.3	1.34 ratio Geometric Coefficient of Variation 39.3	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Days 1 and 15

Accumulation ratio of AUC0-12 was calculated as AUC0-t, after dosing on Day 15 divided by AUC0-t, after dosing on Day 1.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Accumulation Ratio of AUC [Racc (AUC 0-12)] of M3814	2.36 ratio Geometric Coefficient of Variation 34.4	1.57 ratio Geometric Coefficient of Variation 74.0	NA ratio Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	4.32 ratio Geometric Coefficient of Variation 36.7	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1; Pre-dose, 2, 4 and 6 hours post-dose on Day 10

Accumulation ratio of AUC0-12 was calculated as AUC0-t, after dosing on Day 10 divided by AUC0-t, after dosing on Day 1.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=2 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Accumulation Ratio of AUC [Racc (AUC 0-24)] of M3814	NA ratio Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	NA ratio Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	1.44 ratio Geometric Coefficient of Variation 22.9	1.96 ratio Geometric Coefficient of Variation 25.6	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 15

T1/2 was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. T1/2 was calculated by natural log 2 divided by Lambda z. Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=7 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Single Dose: Apparent Terminal Half-life (t1/2) of M3814	2.37 hour Geometric Coefficient of Variation 17.9	3.94 hour Geometric Coefficient of Variation 40.9	2.25 hour Geometric Coefficient of Variation 27.4	5.24 hour Geometric Coefficient of Variation 53.7	3.51 hour Geometric Coefficient of Variation 35.5

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 15

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Multiple Doses: Apparent Terminal Half-life (t1/2) of M3814	5.60 hour Geometric Coefficient of Variation 21.8	6.26 hour Geometric Coefficient of Variation 158.4	NA hour Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	11.4 hour Geometric Coefficient of Variation 60.3	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1;Pre-dose, 2, 4 and 6 hours post-dose on Day 10

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Single Dose: Apparent Terminal Half-life (t1/2) of M3814	NA hour Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	6.56 hour Geometric Coefficient of Variation 30.4	6.95 hour Geometric Coefficient of Variation 33.8	7.79 hour Geometric Coefficient of Variation 39.3	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1;Pre-dose, 2, 4 and 6 hours post-dose on Day 10

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=2 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Multiple Dose: Apparent Terminal Half-life (t1/2) of M3814	NA hour Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	NA hour Geometric Coefficient of Variation NA Geometric mean and Geometric mean coefficient of variation could not be calculated if fewer than 3 participants had reportable parameter values.	7.50 hour Geometric Coefficient of Variation 12.8	11.5 hour Geometric Coefficient of Variation 38.2	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for Vz/f was not collected.

The apparent volume of distribution during the terminal phase following extravascular administration, based on the fraction of dose absorbed. Vz/f = Dose/(AUC0-inf multiplied by Lambda z).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for Vz/f was not collected.

The apparent volume of distribution during the terminal phase following extravascular administration, based on the fraction of dose absorbed. Vz/f = Dose/(AUC0-inf multiplied by Lambda z).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for CL/f was not collected.

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for CL/f was not collected.

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for lambda z was not collected.

Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4 and 6 hour post-dose on Day 1

Population: As described in the Statistical Analysis Plan Section 7 Changes to planned analyses, data for lambda z was not collected.

Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 516 Days)

Population: Safety Analysis Set included all participants who received at least 1 dose of any study intervention.

Blood samples were analyzed by a validated homogenous bridging electrochemiluminescence assay to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Number of Participants With Positive Antidrug Antibody (ADA)	0 Participants	5 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 513 Days)

Population: Safety Analysis Set included all participants who received at least 1 dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Number of Participants With Positive Antidrug Antibody (ADA)	1 Participants	0 Participants	1 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Part FE: From the first study intervention to 508 days

Population: Safety Analysis Set included all participants who received at least 1 dose of any study intervention.

Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Number of Participants With Positive Antidrug Antibody (ADA)	1 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 516 Days)

Population: Full Analysis Set included all participants who received at least 1 dose of any study intervention.

Confirmed BOR was defined as the percentage of participants who achieved confirmed complete responses (CR) or partial response (PR), according to RECIST version 1.1 assessed by the Investigator.CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)= Neither sufficient increase to qualify for progression of disease (PD) nor sufficient shrinkage to qualify for PR. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Confirmed CR=as at least two determinations of CR at least 4 weeks apart with no PD. Confirmed PR=as at least 2 determinations of PR or better (PR followed by PR or PR followed by CR), at least 4 weeks apart (not qualifying for a CR) with no PD in between. Percentage of Participants with confirmed BOR were reported.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Partial Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Stable Disease or Non-CR/Non-PD	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Progressive Disease	2 Participants	7 Participants	0 Participants	2 Participants	1 Participants
Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Not Evaluable	0 Participants	3 Participants	3 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 513 Days)

Population: Full Analysis Set included all participants who received at least 1 dose of any study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Partial Response	0 Participants	0 Participants	0 Participants	0 Participants	—
Part B: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Stable Disease or Non-CR/Non-PD	1 Participants	1 Participants	2 Participants	2 Participants	—
Part B: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Progressive Disease	2 Participants	2 Participants	1 Participants	3 Participants	—
Part B: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Not Evaluable	0 Participants	0 Participants	1 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 404 Days)

Population: Full Analysis Set included all participants who receive at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Complete Response	0 Participants	0 Participants	—	—	—
Part FE: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Partial Response	0 Participants	1 Participants	—	—	—
Part FE: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Stable Disease or Non-CR/Non-PD	2 Participants	1 Participants	—	—	—
Part FE: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Progressive Disease	1 Participants	1 Participants	—	—	—
Part FE: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Not Evaluable	1 Participants	2 Participants	—	—	—

SECONDARY outcome

Timeframe: Time from first documentation of objective response until date of first documentation of PD or death due to any cause, whichever occurred first, assessed up to 516 Days

Population: Full Analysis Set: All participants who receive at least one dose of study intervention. Data could not be calculated as none of the participants showed objective response.

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first documentation of objective response until date of first documentation of PD or death due to any cause, whichever occurred first, assessed up to 513 Days

Population: Full Analysis Set included all participants who receive at least one dose of study intervention. Data could not be calculated as none of the participants showed objective response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first documentation of objective response until date of first documentation of PD or death due to any cause, whichever occurred first, assessed up to 44 Weeks

Population: Full Analysis Set included all participants who receive at least one dose of study intervention. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=1 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator	—	NA months Median and Full range could not be calculated due to insufficient number of events.	—	—	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 516 Days)

Population: Full Analysis Set included all participants who receive at least one dose of study intervention.

Progression-Free Survival was calculated as the time from the start of any study intervention to the date of first documentation of objective progression of disease or death due to any cause, whichever occurs first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The PFS was analyzed by using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Progression-free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator	5.1 months Interval 1.87 to 13.77	1.9 months Interval 0.49 to 14.03	3.3 months Interval 0.03 to 3.68	1.8 months Interval 0.03 to 3.22	2.6 months Interval 0.03 to 2.89

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 513 Days)

Population: Full Analysis Set included all participants who receive at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Progression-free Survival (PFS) Time According to RECIST v 1.1 Assessed by Investigator	1.9 months Interval 1.87 to 3.12	1.7 months Interval 1.68 to 8.34	3.4 months Interval 0.03 to 5.59	1.9 months Interval 0.03 to 5.55	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 404 Days)

Population: Full Analysis Set included all participants who receive at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Progression-free Survival (PFS) Time According to RECIST v 1.1 Assessed by Investigator	2.7 months Interval 0.39 to 5.98	8.5 months Interval 0.69 to 8.51	—	—	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 1359 Days)

Population: Full Analysis Set included all participants who receive at least one dose of study intervention. Here " Overall Number of Participants Analyzed" are equivalent to the number of participants who were evaluable for the outcome measure.

Overall survival was defined as the time from treatment start to the date of death, regardless of the actual cause of the participant's death. The overall survival was analyzed by using the Kaplan-Meier method. Median, is estimated by Kaplan-Meier method which stands for the time that half of the participants are expected to be alive. Depending on the observed number of deaths, time of censoring for each participant, median survival time may not be reached or estimated (few deaths will lead the KM curve never crosses 50% survival line), hence median was not calculable for Part A: M3814 250 mg BID + Avelumab 800 mg Q2W arm. Participants that are still alive at the time of analysis will be censored and counted into the analysis.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Overall Survival	25.5 months Interval 4.8 to 25.53	23.7 months Interval 0.92 to 23.7	NA months Interval 0.76 to 7.13 Median could not be calculated due to insufficient number of death, or the median survival is not reached yet	3.4 months Interval 0.66 to 7.52	7.2 months Interval 2.73 to 7.23

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 1359 Days)

Overall survival was defined as the time from treatment start to the date of death, regardless of the actual cause of the participant's death. The overall survival was analyzed by using the Kaplan-Meier method. Median, is estimated by Kaplan-Meier method which stands for the time that half of the participants are expected to be alive. Depending on the observed number of deaths, time of censoring for each participant, median survival time may not be reached or estimated (few deaths will lead the KM curve never crosses 50% survival line), hence median was not calculable for Part B of the study. Participants that are still alive at the time of analysis will be censored and counted into the analysis.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Overall Survival	NA months Interval 4.01 to 9.0 Median could not be calculated due to insufficient number of death or the median survival is not reached yet.	NA months Interval 3.4 to 19.38 Median could not be calculated due to insufficient number of death or the median survival is not reached yet.	NA months Interval 6.6 to 18.69 Median could not be calculated due to insufficient number of death or the median survival is not reached yet.	NA months Interval 1.08 to 7.98 Median could not be calculated due to insufficient number of death or the median survival is not reached yet.	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 1359 Days)

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Overall Survival	6.4 months Interval 0.39 to 6.41	8.5 months Interval 0.69 to 9.66	—	—	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 516 Days)

Tumor size is derived as the best percent change from baseline in target lesions (sum of longest diameter for non-nodal lesions and short axis for nodal lesions) at each time point.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=2 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part A: Best Percent Change From Baseline in Tumor Size According to RECIST v 1.1	15.8 percent change Standard Deviation 17.27	15.3 percent change Standard Deviation 15.38	-4.5 percent change Standard Deviation 2.34	4.9 percent change Standard Deviation 8.07	13.6 percent change Standard Deviation 26.97

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 513 Days)

Tumor size is derived as the best percent change from baseline in target lesions (sum of longest diameter for non-nodal lesions and short axis for nodal lesions) at each time point.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=5 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Best Percent Change From Baseline in Tumor Size According to RECIST v 1.1	8.4 percent change Standard Deviation 19.59	0.3 percent change Standard Deviation 21.05	-18.5 percent change Standard Deviation 8.19	-0.7 percent change Standard Deviation 19.59	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 404 Days)

Tumor size is derived as the best percent change from baseline in target lesions (sum of longest diameter for non-nodal lesions and short axis for nodal lesions) at each time point.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part FE: Best Percent Change From Baseline in Tumor Size According to RECIST v 1.1	6.1 percent change Standard Deviation 14.98	-13.3 percent change Standard Deviation 27.04	—	—	—

SECONDARY outcome

Timeframe: Time from first study intervention up to long term safety follow-up period (Up to 512.4 Days)

Population: Safety Analysis Set included all participants who received at least one dose of any study intervention.

Number of participants with radiotherapy-induced toxicities (mucositis and radiation dermatitis) were reported.

Outcome measures

Outcome measures
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=3 Participants Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 Participants Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=9 Participants Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.
Part B: Number of Participants With Radiotherapy (RT)-Induced Toxicity According to NCI-CTCAE v 5.0	0 Participants	0 Participants	0 Participants	0 Participants	—

Adverse Events

Part A: M3814 100 mg BID + Avelumab 800 mg Q2W

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A: M3814 200 mg BID + Avelumab 800 mg Q2W

Serious events: 6 serious events

Other events: 11 other events

Deaths: 6 deaths

Part A: M3814 250 mg BID + Avelumab 800 mg Q2W

Serious events: 4 serious events

Other events: 4 other events

Deaths: 3 deaths

Part A: M3814 300 mg BID + Avelumab 800 mg Q2W

Serious events: 4 serious events

Other events: 6 other events

Deaths: 5 deaths

Part A: M3814 400 mg BID + Avelumab 800 mg Q2W

Serious events: 4 serious events

Other events: 4 other events

Deaths: 2 deaths

Part B: M3814 100 mg BID + Avelumab 800 mg Q2W + RT

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: M3814 150 mg BID +Avelumab 800 mg Q2W + RT

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Part B: M3814 200 mg BID + Avelumab 800 mg Q2W + RT

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

Part B: M3814 250 mg BID + Avelumab 800 mg Q2W + RT

Serious events: 6 serious events

Other events: 9 other events

Deaths: 4 deaths

Part Food Effect: M3814 100 mg BID + Avelumab 800 mg Q2W

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Part Food Effect: M3814 200 mg BID + Avelumab 800 mg Q2W

Serious events: 3 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 participants at risk Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 participants at risk Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 participants at risk Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 participants at risk Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 participants at risk Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 100 mg BID + Avelumab 800 mg Q2W + RT n=3 participants at risk Participants received 100 mg of M3814 along with radiotherapy (RT) at 3 grays (Gy) once daily (QD) starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 150 mg BID +Avelumab 800 mg Q2W + RT n=3 participants at risk Participants received 150 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 200 mg BID + Avelumab 800 mg Q2W + RT n=4 participants at risk Participants received 200 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 250 mg BID + Avelumab 800 mg Q2W + RT n=9 participants at risk Participants received 250 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part Food Effect: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 participants at risk Participants were administered 100 mg M3814 tablet orally BID in combination with i.v of avelumab at a dose of 800 mg Q2W throughout the whole study under fasted condition with the exception of fed condition on Day 1 and Day 22. The summary statistics for demographics, safety and efficacy is based on dose level but not fast/fed condition which is not fit for purpose.	Part Food Effect: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 participants at risk Participants were administered 200 mg M3814 tablet orally BID in combination with i.v of avelumab at a dose of 800 mg Q2W throughout the whole study under fasted condition with the exception of fed condition on Day 1 and Day 22. The summary statistics for demographics, safety and efficacy is based on dose level but not fast/fed condition which is not fit for purpose.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Cardiac disorders Acute myocardial infarction	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Cardiac disorders Pericardial effusion	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Autoimmune colitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Colitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Intestinal perforation	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Nausea	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Pancreatitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Vomiting	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Disease progression	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 2/6 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Pyrexia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Hepatobiliary disorders Biliary obstruction	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Pneumonia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Sepsis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Urinary tract infection	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Blood bilirubin increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Blood creatinine increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Gamma-glutamyltransferase increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Lipase increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Neutrophil count decreased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	22.2% 2/9 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Paraesthesia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Renal and urinary disorders Hydronephrosis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Immune-mediated dermatitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days

Other adverse events

Other adverse events
Measure	Part A: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 participants at risk Participants received 100 milligrams (mg) of M3814 orally twice daily (BID) along with 800 mg of Avelumab once every 2 weeks (Q2W) from Day 1 until progressive disease (PD) or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 200 mg BID + Avelumab 800 mg Q2W n=11 participants at risk Participants received 200 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 250 mg BID + Avelumab 800 mg Q2W n=4 participants at risk Participants received 250 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 300 mg BID + Avelumab 800 mg Q2W n=6 participants at risk Participants received 300 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part A: M3814 400 mg BID + Avelumab 800 mg Q2W n=4 participants at risk Participants received 400 mg of M3814 orally BID along with 800 mg of Avelumab Q2W from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 100 mg BID + Avelumab 800 mg Q2W + RT n=3 participants at risk Participants received 100 mg of M3814 along with radiotherapy (RT) at 3 grays (Gy) once daily (QD) starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 150 mg BID +Avelumab 800 mg Q2W + RT n=3 participants at risk Participants received 150 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 200 mg BID + Avelumab 800 mg Q2W + RT n=4 participants at risk Participants received 200 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part B: M3814 250 mg BID + Avelumab 800 mg Q2W + RT n=9 participants at risk Participants received 250 mg of M3814 along with RT at 3 Gy QD starting on Day 1 for 5 days per week for 2 weeks in combination with intravenous infusion of Avelumab at a dose of 800 mg Q2W starting from Day 1 until PD or unacceptable toxicity. M3814 will be administered without food.	Part Food Effect: M3814 100 mg BID + Avelumab 800 mg Q2W n=4 participants at risk Participants were administered 100 mg M3814 tablet orally BID in combination with i.v of avelumab at a dose of 800 mg Q2W throughout the whole study under fasted condition with the exception of fed condition on Day 1 and Day 22. The summary statistics for demographics, safety and efficacy is based on dose level but not fast/fed condition which is not fit for purpose.	Part Food Effect: M3814 200 mg BID + Avelumab 800 mg Q2W n=5 participants at risk Participants were administered 200 mg M3814 tablet orally BID in combination with i.v of avelumab at a dose of 800 mg Q2W throughout the whole study under fasted condition with the exception of fed condition on Day 1 and Day 22. The summary statistics for demographics, safety and efficacy is based on dose level but not fast/fed condition which is not fit for purpose.
Hepatobiliary disorders Cholelithiasis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	18.2% 2/11 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	66.7% 2/3 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Blood and lymphatic system disorders Deficiency anaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Cardiac disorders Angina pectoris	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Cardiac disorders Cardiomegaly	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Cardiac disorders Myocardial ischaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Cardiac disorders Palpitations	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Cardiac disorders Pericardial effusion	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Cardiac disorders Sinus tachycardia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 2/6 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Cardiac disorders Tachycardia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Ear and labyrinth disorders Deafness	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Endocrine disorders Hypothyroidism	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Eye disorders Cataract	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Eye disorders Conjunctival haemorrhage	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Eye disorders Conjunctivitis allergic	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Eye disorders Dry eye	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Eye disorders Periorbital oedema	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Eye disorders Retinal detachment	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Eye disorders Visual field defect	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	27.3% 3/11 • Number of events 4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Abdominal pain upper	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Colitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Constipation	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	27.3% 3/11 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 2/6 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	60.0% 3/5 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	18.2% 2/11 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Flatulence	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Ileal ulcer	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	63.6% 7/11 • Number of events 8 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	75.0% 3/4 • Number of events 4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 2/6 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	44.4% 4/9 • Number of events 4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Oesophagitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Gastrointestinal disorders Vomiting	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	63.6% 7/11 • Number of events 9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	75.0% 3/4 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	44.4% 4/9 • Number of events 5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Adverse drug reaction	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Asthenia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Catheter site irritation	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Chest pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Chills	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	40.0% 2/5 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Fatigue	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	54.5% 6/11 • Number of events 7 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 2/6 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	66.7% 2/3 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	55.6% 5/9 • Number of events 6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	80.0% 4/5 • Number of events 5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Feeling hot	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Gait disturbance	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Influenza like illness	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Mucosal inflammation	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Non-cardiac chest pain	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Oedema peripheral	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Peripheral swelling	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
General disorders Pyrexia	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	36.4% 4/11 • Number of events 4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	60.0% 3/5 • Number of events 4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Conjunctivitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Influenza	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Mucosal infection	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Oral candidiasis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Oral herpes	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Pneumonia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Urinary tract infection	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Infections and infestations Wound infection	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	18.2% 2/11 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	44.4% 4/9 • Number of events 5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	40.0% 2/5 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Injury, poisoning and procedural complications Stoma site haemorrhage	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Alanine aminotransferase increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	27.3% 3/11 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	22.2% 2/9 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	36.4% 4/11 • Number of events 4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	66.7% 2/3 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	18.2% 2/11 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Blood bilirubin increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Blood creatine phosphokinase increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	75.0% 3/4 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Blood creatinine increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Blood phosphorus increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Blood thyroid stimulating hormone increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Electrocardiogram QT prolonged	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Electrocardiogram T wave abnormal	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Gamma-glutamyltransferase increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	66.7% 2/3 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Lymphocyte count decreased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Neutrophil count decreased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Platelet count decreased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	66.7% 2/3 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Troponin I increased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 2/6 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations Weight decreased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Investigations White blood cell count decreased	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	45.5% 5/11 • Number of events 5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 2/6 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 3/9 • Number of events 4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	40.0% 2/5 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hypoalbuminaemia	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	18.2% 2/11 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	75.0% 3/4 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	18.2% 2/11 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 2/6 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	40.0% 2/5 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	60.0% 3/5 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	27.3% 3/11 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 2/6 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	75.0% 3/4 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	18.2% 2/11 • Number of events 4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	40.0% 2/5 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Cognitive disorder	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Dizziness	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Dysgeusia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Encephalopathy	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Headache	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Paraesthesia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Peroneal nerve palsy	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Presyncope	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Somnolence	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Syncope	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Nervous system disorders Tremor	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Psychiatric disorders Agitation	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Psychiatric disorders Confusional state	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Psychiatric disorders Delirium	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Psychiatric disorders Depression	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Psychiatric disorders Insomnia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Renal and urinary disorders Dysuria	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Renal and urinary disorders Haematuria	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Renal and urinary disorders Malignant urinary tract obstruction	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Renal and urinary disorders Nocturia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Renal and urinary disorders Renal failure	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Renal and urinary disorders Urinary retention	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	18.2% 2/11 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 3/6 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	75.0% 3/4 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 3/6 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 3/9 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Pulmonary pain	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	18.2% 2/11 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	60.0% 3/5 • Number of events 4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	45.5% 5/11 • Number of events 5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	16.7% 1/6 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	20.0% 1/5 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 1/3 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	40.0% 2/5 • Number of events 2 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	11.1% 1/9 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Vascular disorders Deep vein thrombosis	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Vascular disorders Flushing	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Vascular disorders Hot flush	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/11 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/6 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days
Vascular disorders Hypotension	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	9.1% 1/11 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	33.3% 2/6 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	25.0% 1/4 • Number of events 1 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	50.0% 2/4 • Number of events 3 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/9 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/4 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days	0.00% 0/5 • Adverse events were assessed from first study intervention up to long term safety follow-up period (Up to 516 Days in Part A, Up to 513 days in Part B, Up to 404 days in Part FE); All-cause mortality was assessed up to 1359 days

Additional Information

Communication Center

Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place